Healthcare

Coverage for citizens and long-term residents

Health coverage would be guaranteed to all U.S. citizens and people who have lived here long-term. Residency status alone would not be grounds for denying care.

Residency requirement for elective care

Planned, non-urgent procedures would be available only to people who live in the country. Emergency care would remain available to everyone regardless of where they live.

Exception for severe conditions

People with severe or life-threatening conditions would receive full coverage for necessary care even if they do not meet ordinary residency requirements.

High-risk AI classification

AI tools used in healthcare would be treated as high-risk technology, meaning they would have to meet strict safety and accountability standards before being used with patients.

AI systems in healthcare must be treated as high-risk systems requiring strict standards for safety efficacy accountability and patient protection

AI as support, not replacement

AI can help doctors, but it cannot replace them. Licensed medical professionals must remain in charge of diagnosing patients and deciding on treatment.

AI systems may support but not replace licensed medical professionals in diagnosis treatment decisions or patient care where such care is medically required

Clinical decision support limits

AI can help a doctor think through options, but cannot make the final call. Any AI used in clinical settings must support—not replace—a physician's own judgment.

AI systems may be used for clinical decision support only where they assist rather than substitute for physician judgment

Evidence standards before deployment

Before an AI tool can be used with real patients, it must have solid proof that it is safe, works as claimed, and does not treat some patient groups less fairly than others.

AI systems must meet strong evidence standards for safety efficacy and bias before being used in clinical settings

Continuous monitoring requirement

Once deployed, AI systems in healthcare must be continuously watched for errors, bias, and harmful outcomes—not just tested once before launch.

Deployed healthcare AI systems must be continuously monitored for errors bias and adverse outcomes

No independent diagnosis or prescription

AI cannot independently diagnose a patient or prescribe treatment on its own. A qualified human must always be in the loop and accountable for those decisions.

AI systems may not independently diagnose or prescribe treatment without qualified human oversight and accountability

Independent clinical judgment required

When a human reviewer is required to check an AI decision, they must genuinely think it through themselves—they cannot simply rubber-stamp whatever the AI recommended.

Human reviewers must exercise independent clinical judgment and may not rely solely on AI-generated recommendations when making decisions that affect access to care

AI for approval only, not denial

AI can be used to speed up approvals for care, but it cannot be the primary reason care is denied. Denials still require independent human clinical review.

AI systems may be used to assist or expedite approval of care but may not be used as the primary basis for denial restriction or reduction of care

Prior human review for denials

A human reviewer must look at a case before any care is denied—decisions cannot be delegated to an appeal process after the fact.

Human review must occur prior to any denial decision and may not be deferred to post-decision appeal processes

Absence of AI approval not grounds for denial

Insurers cannot use the fact that an AI system did not flag or recommend a treatment as a basis for denying it.

Absence of AI approval or recommendation may not be used as evidence justification or implicit basis for denial restriction or limitation of care

Independent evaluation required for denials

Every denial of care must be based on an independent clinical evaluation, not just the absence of AI support or an algorithm's output.

All denial decisions must be based on independent clinical evaluation and evidence and may not rely on absence of AI support or AI-generated prioritization

No systemic bias from AI prioritization

AI systems that help process care requests must be monitored to ensure they are not systematically making it harder for certain groups of patients to get approved.

AI systems used to assist approvals must not create systemic bias in review processes that increases likelihood of denial for cases not flagged or prioritized by AI

Equal human consideration for non-AI-flagged cases

Care requests that an AI did not highlight must still receive timely human review—patients should not be deprioritized just because an algorithm did not flag their case.

Case review systems must ensure that requests not prioritized or flagged by AI receive equal and timely human consideration

No opaque triage decisions

AI systems that sort and prioritize care requests must be explainable and subject to oversight—black-box triage that affects patient care is not allowed.

AI systems may not make opaque triage or prioritization decisions that materially affect access to care without explainability and oversight

Access to explanations and appeals

When an AI system influences a coverage decision, patients and their doctors have the right to a clear explanation of how that decision was made and the ability to appeal it.

Patients and providers must have access to explanations and appeal processes for AI-influenced coverage decisions

Right to human care

Patients have the right to receive care from a qualified human provider and cannot be forced to use AI-only care pathways as their only option.

Patients have the right to receive care from qualified human providers and may not be forced into AI-only care pathways

Informed consent and opt-out

Patients must be told when AI is being used in their care and must be able to opt out where that is feasible.

Patients must be informed when AI systems are used in their care and must be able to opt out where feasible

Strict data protections

Healthcare data used by AI systems must be treated as highly sensitive and protected with strict safeguards against misuse, sharing, or unauthorized access.

Healthcare data used by AI systems must be treated as highly sensitive with strict protections against misuse or unauthorized access

No commercial data exploitation

A patient's healthcare data cannot be used by AI systems for advertising, commercial profiling, or any purpose unrelated to their care.

Healthcare data may not be used for advertising profiling or unrelated commercial purposes

Training data ethical standards

The data used to train AI healthcare tools must have been collected legally, ethically, and with proper consent from patients.

Training data for healthcare AI must meet strict ethical legal and consent standards including safeguards against re-identification

Fail-safe design

If an AI healthcare system is uncertain or encounters a situation outside its training, it must fail safely and hand off to a qualified human provider rather than improvising.

Healthcare AI systems must fail safely and defer to human providers when uncertain or operating outside validated scope

No unwarranted certainty

AI tools used in clinical settings must not present their outputs as more certain than they actually are, since false confidence can lead to serious medical errors.

AI systems may not present outputs with unwarranted certainty in clinical contexts where uncertainty materially affects outcomes

Bias evaluation and mitigation

AI systems used in healthcare must be regularly tested to ensure they do not perform worse for patients based on race, gender, income, or other characteristics.

Healthcare AI systems must be evaluated and mitigated for bias across race gender socioeconomic status and other protected characteristics

No disparity worsening

Healthcare AI cannot be deployed in ways that make existing gaps in access or quality worse for underserved communities.

AI deployment must not worsen disparities in healthcare access or outcomes

AI for research acceleration

AI can be used to accelerate medical research and drug development, as long as it meets the same safety, transparency, and ethics standards applied to traditional research.

AI may be used to accelerate medical research and drug development provided it meets safety transparency and ethical standards

Research funding for neglected conditions

Federal research funding would be directed toward conditions and treatments that have been historically overlooked or underfunded relative to how many people they affect.

Increase funding for research into under-studied conditions treatments and medications including diseases that are historically neglected or lack commercial incentives

Priority for underfunded diseases

Government research priorities must include common but underfunded diseases—not just conditions that attract the most commercial investment.

Public funding priorities must include diseases and conditions that are prevalent but underfunded including sexually transmitted infections chronic conditions and non-commercial research areas

Science-based AI policy

Rules about which AI tools are allowed in healthcare must be based on transparent, evidence-based science, free from commercial or political pressure.

Healthcare AI policy and approvals must be grounded in transparent evidence-based science and protected from political ideological or commercial distortion

Safe AI integration

AI must be brought into healthcare systems in ways that maintain safety, clear accountability, and continuity of care for patients.

AI systems must be integrated into healthcare systems in ways that preserve safety accountability and continuity of care

Interoperability with privacy protections

Healthcare AI systems should be designed to share data across systems in ways that are useful for patients, while fully protecting privacy and security.

Healthcare AI systems should support interoperability and data portability without compromising privacy or security

Fast, meaningful, independent appeals

When a patient's coverage is denied or a service is refused, they and their doctor must have access to a fast, meaningful, and genuinely independent appeal process.

Patients and providers must have access to fast meaningful and independent appeal processes for adverse coverage or service decisions

Urgent appeal timelines

If a delay in coverage could harm or worsen a patient's condition, the appeal must be resolved fast enough to prevent that harm—urgency must be factored into the timeline.

Appeals involving urgent medically necessary treatment must be resolved on timelines that prevent avoidable deterioration injury or death

Independent external review

An independent reviewer—not someone connected to the insurer that issued the denial—must be available to review disputed coverage decisions.

Independent external review must be available for contested denials and may not be controlled by the same entity that issued the denial

Pattern review and penalties

When an appeal is won, the insurer must examine the pattern of similar denials, and face penalties if the same unjustified denial is happening repeatedly.

Successful appeals should trigger review of the underlying denial patterns and potential penalties for repeated wrongful denials

Ban tiered healthcare coverage

There would be one standard of healthcare coverage for everyone—no tiered system where wealthier people get access to better care.

Single plan for all

Everyone would be enrolled in the same health plan, eliminating the complexity of multiple competing insurance options with different levels of coverage.

Single payer healthcare

The government would take over health insurance through a single national plan, ending the private insurance system for covered services.

Tighter denial limits

Stricter rules would cap how often and why insurers can say no to coverage or services, making it harder for insurance companies to deny necessary care.

Establish tighter overall rules limiting denial of healthcare coverage or service

Overhaul insurance to reduce denials

While the country moves toward universal healthcare, the insurance system would be overhauled to reduce the frequency of denials, delays, and gaps that leave people without covered care.

Until universal healthcare is implemented overhaul health insurance to reduce denials delays and gaps in coverage

Faster coverage decision timelines

Insurers would be required to make coverage and prior authorization decisions within set time limits, so patients are not left waiting indefinitely for decisions.

Require faster timelines for healthcare coverage decisions and prior authorization determinations

Expedited appeal processes

When coverage is denied, the appeals process would be fast enough to prevent patients from going without care while waiting for a decision.

Require expedited appeal processes for denials of healthcare coverage or service

Increase required coverage

Insurers would be required to cover more medicines, procedures, and treatments that are medically necessary, reducing the number of things patients must pay for out of pocket.

Increase required coverage of medicines procedures and medically necessary treatments

Protect pre-existing condition bans

Insurance companies could not refuse to cover someone because of a health condition they already had—these protections would be permanent and harder to roll back.

Protect and strengthen bans on denial of coverage based on pre-existing conditions

Expand coverage for under-covered conditions

Coverage requirements would expand to include conditions that have historically been ignored or underfunded by insurers, such as obesity and related care.

Expand required coverage for conditions that are often under-covered including obesity

Require mental healthcare coverage

Health plans would be required to cover mental health treatment, including talk therapy, on equal terms with physical healthcare.

Require coverage of mental healthcare including talk therapy

Psychedelic therapy coverage

Where the evidence supports it and the law allows it, coverage would include psychedelic-assisted therapy administered under appropriate medical supervision.

Require coverage of psychedelic therapy where medically appropriate and supported by evidence and law

Nationwide in-network care

Health plan networks would work everywhere in the country, not just in the region where someone enrolled—patients could see doctors in any state without penalty.

Require health plans to provide nationwide in-network care rather than only regional networks

Expand HSA-style tools

Health savings accounts (HSAs) and similar spending tools would be available to everyone, not just people enrolled in high-deductible insurance plans.

Expand HSA-style health spending cards or equivalent healthcare spending access tools to everyone rather than limiting them to high-deductible plans

Ban high-deductible-only plans

Employers could not meet their coverage obligations by offering only high-deductible health plans, which shift large costs onto employees before insurance kicks in.

Ban employers from offering only high-deductible health insurance plans

Employers pay all premiums

Employers would be required to pay the full cost of employees' health insurance premiums, with defined exceptions and support for small businesses.

Require employers to pay all health insurance premiums subject to defined exceptions carveouts and subsidies for small businesses

Fair coverage processes

Coverage or services could not be denied, restricted, or delayed except through a fair, transparent process based on real medical evidence and individual circumstances.

Healthcare coverage or service may not be denied restricted or delayed except through fair transparent timely and medically grounded review processes

Clear standards for denials

Every denial of coverage must be based on clear medical standards applied to the individual patient's situation—blanket exclusions and automated denials would not be enough.

Any adverse coverage decision must be based on clear medical standards and individualized review rather than blanket exclusions automated inference or procedural traps

Public reporting of denial rates

Insurers would be required to publicly report how often they deny claims, what those patterns look like, and how often denials are reversed on appeal.

Denial rates delay patterns and reversal rates must be publicly reported and subject to oversight and enforcement

Penalties for repeated unjustified denials

Insurers that repeatedly deny medically necessary care without justification would face penalties, corrective action requirements, and potentially lose the ability to participate in public programs.

Repeated unjustified denial or delay of medically necessary care must trigger penalties corrective action and possible loss of plan participation authority

Mandatory care floor

All coverage systems would be required to cover a broad floor of essential care—preventive, acute, chronic, reproductive, mental health, and disability-related services.

Coverage systems must include a broad mandatory floor of medically necessary care including preventive acute chronic reproductive mental and disability-related care

No vague exclusions

Coverage exclusions would have to be written precisely—vague language that effectively blocks necessary care would not be allowed.

Coverage exclusions may not be written so broadly or vaguely that they undermine the practical availability of necessary care

Clear language and pro-access interpretation

Coverage rules would be written in clear language, and whenever the meaning is unclear, it would be interpreted in favor of the patient getting care.

Coverage rules must be written in clear language and interpreted in favor of access where ambiguity exists in medically necessary care

Evidence-based coverage inclusion

Coverage systems would be required to include treatments, medications, and diagnostics that are supported by evidence and appropriate for a patient's individual situation.

Coverage systems must include medicines procedures therapies and diagnostics that are supported by evidence and medically appropriate for the individual patient

Permanent pre-existing condition protections

Protections against being denied coverage for pre-existing conditions would be made permanent and explicitly resistant to being weakened or removed.

Protections against denial or exclusion based on pre-existing conditions must be permanent explicit and difficult to weaken or roll back

No indirect pre-existing condition exclusion

Insurance companies could not find workarounds to discriminate against people with pre-existing conditions through pricing, network design, or other indirect tactics.

Coverage systems must not use pre-existing-condition logic indirectly through pricing network design utilization controls or exclusionary administration

Expand historically under-covered conditions

Required coverage would expand to include conditions historically denied or stigmatized by insurers, such as obesity, chronic pain, and sexually transmitted infections.

Coverage requirements must be expanded for conditions that have historically been under-covered or stigmatized including obesity chronic pain sexually transmitted infections and other neglected areas

Mental health parity

Mental healthcare—including therapy, psychiatric care, crisis services, and longer-term treatment—would be covered on equal terms with physical healthcare.

Coverage systems must include mental healthcare on parity with physical healthcare including talk therapy psychiatric care crisis services and medically appropriate longer-term treatment

No mental health access discrimination

Insurers could not make mental healthcare harder to access than physical healthcare through narrower networks, stricter utilization controls, or other tactics.

Coverage systems may not impose narrower networks harsher utilization controls or lower practical access for mental healthcare than for physical healthcare

Emerging evidence-based therapies

Where evidence and law support it, coverage would include therapies like psychedelic-assisted treatment under proper medical supervision.

Where evidence and law support it coverage systems should include therapies such as psychedelic-assisted treatment under appropriate medical supervision

Preventative care coverage mandate

All health plans would be required to cover preventive care at no cost to the patient—including annual physicals, cancer screenings, and mental health screenings.

All coverage systems must cover preventative care at no cost to the patient — including annual physicals, cancer screenings, metabolic panels, cardiovascular risk assessment, mental health screenings, and vision and dental screenings. Preventative care is not optional coverage and may not be excluded, cost-shared, or subject to prior authorization requirements that effectively eliminate access.

Weight management as covered care

Weight management services—including nutrition counseling, supervised programs, FDA-approved medications, and surgery when clinically indicated—would be covered as preventive care.

Weight management services — including nutrition counseling, medically supervised programs, FDA-approved medications, and bariatric surgery where clinically indicated — must be covered as preventative and chronic disease management care. Obesity is a medical condition, not a moral failing. Coverage systems may not categorically exclude weight management services; coverage decisions must be based on clinical criteria, not assumptions about patient behavior or character.

Preventative mental wellness visits

Coverage would include annual mental wellness visits with a licensed professional, separate from treatment visits, to support ongoing wellness and early identification of concerns.

Coverage must include annual mental wellness visits with a licensed mental health professional, distinct from treatment visits. These visits are for ongoing wellness and early identification of concern, not for diagnosing illness. They may not be billed or classified as diagnostic or treatment encounters, and utilization of wellness visits may not be used to impose treatment requirements, increase premiums, or otherwise disadvantage the patient.

Cosmetic and reconstructive procedures for documented mental or emotional health

When a licensed psychiatrist or psychologist documents that a physical condition causes severe mental or emotional distress that significantly impairs daily functioning, procedures addressing that condition would be covered.

Coverage systems must cover procedures where a licensed psychiatrist or psychologist has documented that a condition causes severe mental or emotional distress that substantially impairs daily functioning. This includes: gender-affirming procedures, which must be covered regardless of this rule; procedures to correct disfigurement or asymmetry causing documented psychological distress; and treatment of conditions affecting appearance that cause clinical-level body dysmorphia or depression. The standard is clinical determination by a licensed mental health professional, not patient preference alone.

Chronic pain as a covered primary condition

Chronic pain lasting three or more months would be covered as a primary medical condition, not just managed with opioid prescriptions. Coverage would include pain specialists, physical therapy, and non-opioid treatments.

Chronic pain lasting three or more months must be covered as a primary medical condition, not merely managed with opioid prescriptions. Coverage must include pain management specialists, physical therapy, alternative pain management modalities (including acupuncture and interventional procedures), psychological pain management, and investigational pain treatments under the RTT framework where applicable. Coverage systems may not limit chronic pain coverage to opioid prescribing as the sole covered pathway.

Functional medicine and quality-of-life care for chronic conditions

For people with chronic conditions, coverage would include care focused on improving daily function and quality of life—not just emergency and acute care.

Coverage must include care aimed at optimizing function and quality of life for people with chronic conditions — not only emergency and acute care. Covered care includes functional assessments, rehabilitation services, assistive devices, and personalized care plans for managing chronic conditions. Coverage systems may not limit chronic condition management to acute interventions while excluding rehabilitative, functional, and quality-of-life-directed care.

Cost-sharing must not block access

Deductibles and copays could not be set so high that they effectively block people from using their coverage—the point of insurance is to make care accessible.

Deductibles copays and out-of-pocket cost structures must not make covered care practically inaccessible

Regulate cost-sharing for patient protection

Rules about cost-sharing would be regulated to protect patients from financial shocks, care delays, and being priced out of treatments they technically have coverage for.

Healthcare cost-sharing rules must be regulated to protect patients from financial shock delay of care and medically harmful underuse

Broad health spending tool access

Health savings tools would be widely available so more people can pay for care in a tax-advantaged way, without being required to be in a high-deductible plan.

Health spending cards or equivalent patient-directed tools should be available broadly rather than limited to high-deductible-plan structures

No cost barriers for chronic/preventive care

Cost-sharing structures could not be designed in ways that discourage people from getting care for chronic conditions, disabilities, or preventive treatments.

Cost-sharing design may not be used to discourage care for chronic conditions disability-related needs or preventive treatment

No high-deductible-only employer plans

Employers could not fulfill their healthcare obligation by offering only high-deductible plans that shift large costs to workers before any coverage kicks in.

Employers may not satisfy healthcare obligations by offering only high-deductible plans that shift unreasonable cost burden onto workers

Employers pay full premiums

Employers would be required to pay the full cost of workers' health insurance premiums, with defined exceptions and support for small businesses.

Employers should be required to pay the full premium cost of employee health coverage subject to clearly defined exceptions carveouts and small-business supports

Small business supports

Small businesses would receive government subsidies or other supports to help them provide health coverage without threatening their financial stability.

Small businesses should receive subsidies public supports or transition assistance to comply with healthcare coverage obligations without destabilization

Prevent underinsurance disguised as coverage

During any transition period, employer coverage rules would be written to prevent nominal plans that look like coverage but leave workers effectively uninsured.

Employer-based health coverage rules during the transition period must be structured to prevent underinsurance disguised as nominal coverage

Emergency care free for all

Emergency medical care would be free for everyone at the point of service—no one would face a bill for going to the emergency room in a crisis.

Emergency includes ambulance and follow-up

Emergency coverage would include ambulance transportation and necessary follow-up care after an emergency, not just the initial visit.

Mental healthcare must be included

Mental healthcare must be covered as a core part of any health plan, not treated as optional or secondary to physical care.

Mental health AI as high-risk

AI systems used in mental health settings would be regulated as high-risk because mistakes can affect safety, privacy, and a person's access to essential care.

AI systems in mental health must be regulated as high-risk because they can affect safety autonomy privacy dignity and access to care

AI may not replace clinicians in high-risk determinations

AI cannot replace licensed mental health clinicians for high-stakes decisions like diagnosis, crisis assessment, or involuntary treatment. A real professional must always make those calls.

AI systems may not replace licensed clinicians in diagnosis crisis assessment involuntary treatment decisions or other high-risk mental health determinations

No AI-only suicide/crisis decisions

AI cannot be the sole decision-maker in suicide risk assessment or mental health crisis response. A qualified human must always be in the loop.

AI systems may not serve as the sole decision-maker in suicide risk assessment crisis intervention or emergency mental health response

Human accountability required

A clearly identified licensed professional must remain personally accountable for any high-risk mental health decision that involved an AI system.

A clearly identifiable licensed human professional must remain accountable for all high-risk mental health decisions involving AI systems

AI as assistive tool only

AI can be a helpful tool in mental healthcare, but only where it supports—rather than stands in for—qualified clinical judgment.

AI may be used as an assistive tool in mental healthcare only where it supports rather than substitutes for qualified clinical judgment

Evidence standards for mental health AI

AI tools used in mental health care must have strong, peer-reviewed evidence that they are safe, effective, and unbiased before they can be deployed.

AI systems used in mental health care must meet strong evidence standards for safety efficacy and bias before deployment

Continuous monitoring for mental health AI

Mental health AI systems must be continuously monitored after launch for harmful outcomes, bias, and failure modes—not just approved once and left unchecked.

Mental health AI systems must be continuously monitored for harmful outcomes bias failure modes and adverse effects after deployment

No deceptive AI therapist presentation

Apps and AI tools marketed for mental health support could not pretend to be human therapists or build false impressions of a human relationship.

AI systems marketed for mental health support may not deceptively present themselves as human therapists clinicians or trusted personal relationships

No emotional dependency cultivation

AI tools marketed for mental health support could not be designed to create emotional dependency or compulsive usage in people seeking help.

AI systems may not be designed to cultivate emotional dependency attachment or compulsive engagement in users seeking mental health support

Clear AI disclosure

Any AI system offering mental health support must clearly state that it is not a human and explain its limitations in plain language.

Any AI system offering mental health support must clearly disclose that it is not a human and must state its limits in plain language

Special protections for minors

Children and teenagers using AI tools that offer emotional or behavioral support would have extra protections, given their vulnerability to influence and manipulation.

Special protections are required for minors using AI systems offering emotional support companionship or mental health-related interaction

Escalation pathways to human care

Mental health AI systems must be able to connect users to human crisis resources or emergency services when the system detects serious risk—not try to handle crises on its own.

Mental health AI systems must include clear escalation pathways to human crisis resources emergency services or licensed care when high-risk indicators are detected

No false reassurance

AI in crisis support settings must not offer false reassurance or act more certain than it is—incorrect confidence in a mental health emergency can cost lives.

Mental health AI systems may not provide false reassurance or simulate certainty in crisis situations beyond validated capability

Fail safely to human care

If a mental health AI system encounters something beyond its capabilities, it must direct the user to a human rather than improvising an unsupported response.

Where mental health AI systems are uncertain or out of scope they must fail safely and direct users to human care rather than improvising unsupported guidance

Enhanced mental health data privacy

Information shared with AI mental health tools must be treated as highly sensitive health data, with strong privacy protections equivalent to clinical records.

Data generated through AI mental health interactions must be treated as highly sensitive health data with enhanced privacy protections

No commercial mental health data exploitation

Mental health data collected by AI tools could not be sold, used for advertising, or used to build commercial profiles of users.

Mental health AI data may not be sold shared for advertising or used for unrelated profiling or commercial targeting

No discriminatory use of mental health data

Mental health data collected by AI could not be used by employers, insurers, schools, or landlords to deny someone a job, coverage, enrollment, or housing.

Mental health data inferred or collected by AI systems may not be used by employers insurers schools or landlords to deny opportunity coverage or access

Explicit informed consent

Users of mental health AI tools must give explicit, informed, and revocable consent for data use—no hidden settings or deceptive consent flows.

Consent for use of mental health AI systems and their data practices must be explicit informed revocable and presented without dark patterns

Evidence required for efficacy claims

AI tools cannot claim mental health or therapeutic benefits without scientific evidence that actually supports those specific claims.

AI systems may not claim mental health efficacy diagnostic power or therapeutic value without scientifically supported evidence appropriate to those claims

Independent evaluation required

Mental health AI systems must be evaluated by independent researchers, not just based on the company's own internal testing or marketing.

Mental health AI systems must be subject to independent evaluation rather than relying solely on vendor claims or internal testing

Disclose risks and failure modes

The public must be able to see clear information about the known risks, limitations, and failure modes of AI mental health systems.

Material risks limitations and known failure modes of mental health AI systems must be publicly disclosed

Right to human mental healthcare

People must always have the option to access human mental healthcare and cannot be directed to AI-only services because of cost or convenience decisions by payers.

People must retain a right to access human mental healthcare and may not be forced into AI-only mental health services because of cost convenience or availability policies

Coercive AI deployment safeguards

AI mental health tools cannot be imposed on people in schools, workplaces, prisons, or benefits systems without strong legal safeguards and voluntary consent.

AI mental health tools may not be imposed coercively in schools workplaces prisons detention settings or public benefits systems without strict legal safeguards

No behavioral conformity enforcement

AI tools cannot be used to pressure people into certain behaviors or ideological conformity under the guise of providing mental health support.

AI systems may not be used to enforce behavioral conformity or ideological compliance under the guise of mental health support

School AI risk-scoring restrictions

Schools cannot use opaque AI tools to label, track, or score students' mental health or risk levels without strict legal and scientific oversight.

Schools may not rely on opaque AI mental health or risk-scoring tools to label discipline or surveil students without strict legal and scientific safeguards

Prison/detention AI restrictions

Jails and prisons cannot use AI mental health tools to justify isolating, restraining, or forcing treatment on incarcerated people without rigorous human review and legal protections.

Jails prisons detention facilities and similar institutions may not use AI mental health tools to justify isolation restraint forced treatment or punishment without rigorous human review and legal safeguards

Public benefits AI assessment limits

Public benefits and disability systems cannot use opaque AI mental health assessments to deny support or override the judgment of licensed clinical evaluators.

Public benefits or disability systems may not use opaque AI mental health assessments to deny support or override licensed clinical evaluations

Insurers may not use AI to deny mental health care

Insurance companies cannot use AI to deny, delay, or cut back mental health care in ways that override a licensed clinician's judgment without transparent review and an appeal process.

AI systems may not be used by insurers or payers to deny delay or limit mental health care in ways that override licensed clinical judgment without transparent review and appeal

AI not substitute for licensed care

AI cannot be used as a substitute for access to licensed mental health care when that care is medically appropriate—it can supplement but not replace.

AI systems may not be used as a substitute for access to licensed mental health care where such care is medically appropriate

Data retention limits and user control

Mental health AI systems must strictly limit how long they retain sensitive personal data and must give users meaningful control, including the ability to delete their information.

Mental health AI systems must implement strict limits on data retention including user control over deletion and limits on persistent memory of sensitive interactions

Training data consent standards

Data used to train mental health AI systems cannot include sensitive personal disclosures or confidential therapy content that was not obtained with proper consent.

Training data for mental health AI systems must not include improperly obtained sensitive personal disclosures or confidential therapeutic data

Clear capability limits

Mental health AI systems must clearly define what they can and cannot do, and must not imply they understand patients the way a human clinician would.

Mental health AI systems must clearly define their role capabilities and limitations and may not imply comprehensive understanding or human-like judgment

No manipulative behavior modification

AI systems cannot use mental health interactions to shape a person's behavior for commercial or institutional goals without their explicit knowledge and consent.

AI systems may not use mental health interactions to manipulate behavior for productivity commercial or institutional objectives without explicit informed consent and safeguards

No surveillance integration

Mental health AI systems cannot be connected to surveillance, law enforcement, or intelligence systems to monitor or profile individuals.

Mental health AI systems may not be integrated with surveillance law enforcement or intelligence systems to monitor or profile individuals

Research ethical review standards

When AI mental health tools are used in research or experimental settings, they must meet full human subjects research standards, including informed consent and ethics review.

Use of AI mental health systems in experimental or research contexts requires informed consent and appropriate ethical review equivalent to human subjects research standards

Fund independent AI mental health research

Independent research into the effects of AI tools on mental health—especially for children, teenagers, and vulnerable adults—would receive dedicated federal funding.

Fund independent research into the short-term and long-term effects of AI systems on mental health including impacts on children adolescents and vulnerable populations

Ban conversational AI for young children

AI systems designed for conversation, emotional interaction, or behavioral guidance could not be marketed or deployed for children under a minimum age, such as eight years old.

Ban use of AI systems designed for conversational emotional or behavioral interaction for children under a minimum age threshold such as 8 years old

Graduated age-based AI restrictions

Age-based restrictions would apply to AI systems that simulate social, emotional, or advisory relationships, with stronger safeguards for younger users.

Establish graduated age-based restrictions for AI systems that simulate social emotional or advisory interaction with increasing safeguards for minors

Minor-accessible AI data limits

AI tools accessible to minors would be required to limit data collection and restrict the behavioral influence techniques they can use.

AI systems accessible to minors must include strict limitations on data collection interaction patterns and behavioral influence mechanisms

No direct-to-consumer mental health AI treatment

AI tools could not be sold directly to consumers as standalone mental health treatment—they would only be allowed in clinically supervised settings.

AI systems may not be marketed or deployed as standalone mental health treatment tools directly to consumers outside of clinically supervised contexts

Limited crisis support AI

In limited circumstances, AI tools could be used for crisis support, but only if they are designed solely to provide immediate help and escalate to human services.

Limited use of AI systems for crisis support may be permitted where they are designed solely to provide immediate assistance and escalation to human services such as suicide prevention resources

Clinical data consent for training

Mental health data from licensed therapy sessions or clinical records could not be used to train AI systems without explicit informed consent from the people whose data it is.

Mental health data from licensed providers therapy sessions or clinical records may not be used for AI training without explicit informed consent from all parties involved

Identifiable clinical data training prohibition

Using identifiable mental health records to train AI is prohibited unless strict ethical, legal, and consent standards are met.

Use of identifiable clinical mental health data for AI training is prohibited unless strict ethical legal and consent standards are met

Mental health interaction data storage limits

Mental health data collected through AI interactions could not be stored beyond what is strictly necessary without the user's explicit ongoing consent.

Mental health data generated through AI interactions may not be stored beyond what is strictly necessary without explicit informed consent and user control

Robust de-identification for training data

All training data for mental health AI must be thoroughly de-identified using robust methods, with ongoing safeguards to prevent re-identification.

All training data used in mental health AI systems must be de-identified using robust techniques with safeguards against re-identification and ongoing evaluation of anonymization effectiveness

No re-identification of anonymized data

AI systems cannot be designed or used to identify individuals from anonymized mental health data sets.

AI systems must not be designed or used to re-identify individuals from anonymized mental health data

Adequate networks for all services

Health plans would be required to maintain adequate networks of providers for all covered services—including specialists and mental healthcare—so covered care is actually accessible.

Health plans must maintain adequate networks for all covered services including specialty care mental healthcare emergency care and chronic-condition management

National networks required

Health plan networks would work across the whole country, not just the region where someone enrolled, so people are not stuck without in-network care when they travel or move.

Health plan networks must function nationally rather than trapping people in narrow regional structures that block continuity or mobility

Out-of-network coverage when network inadequate

If a health plan cannot provide adequate in-network care within a reasonable time and distance, the plan would be required to cover out-of-network care at in-network rates.

If adequate in-network care is not available within reasonable time and distance standards out-of-network care must be covered at in-network cost to the patient

No patient penalty for network failures

Patients cannot be penalized financially for going outside a narrow network when their plan failed to provide meaningful access to the care they needed.

Patients may not be penalized for obtaining necessary care outside narrow networks when the plan fails to provide meaningful access

Public reporting of coverage metrics

Insurers and other coverage entities would be required to publicly report how often they deny claims, how long delays typically last, and how often denied claims are reversed on appeal.

Coverage entities must publicly report denial rates appeal outcomes prior authorization burden network adequacy failures and major access complaints in standardized formats

Oversight authority and enforcement

Healthcare oversight bodies would have real enforcement authority to investigate patterns of denial, delay, and undercoverage—and to impose meaningful consequences when coverage systems fail patients.

Healthcare oversight bodies must have authority to investigate systemic denial delay undercoverage or misleading plan design and impose meaningful penalties

No hiding behind proprietary claims

Clear penalties and remedies would apply when healthcare coverage systems systematically deny or delay care, so the consequences of harm to patients are real and enforceable.

Coverage entities may not hide harmful practices behind proprietary standards trade secrecy or intentionally complex plan language

Corrective action and suspension authority

Patients would have the right to sue when coverage rules are violated in ways that delay or deny their care, giving them a direct legal remedy beyond the complaint process.

Regulators must be empowered to require corrective action restitution or suspension of plan participation where repeated patient harm occurs

Strict limits on prior authorization

Prior authorization—the requirement to get insurer approval before receiving care—would be strictly limited to cases with clear evidence that it prevents overuse. It could not be applied routinely to standard care.

Prior authorization requirements must be strictly limited to categories with clear evidence of necessity and may not be used indiscriminately across routine care

Transparent prior authorization systems

When prior authorization is required, the process must be transparent, clinically grounded, and easy for patients and their doctors to navigate without unnecessary complexity.

Prior authorization systems must be transparent clinically justified and easy for providers and patients to navigate

Reduce repeated prior authorization burden

Once a type of care has been approved multiple times for the same patient, the burden of repeatedly seeking re-authorization would be reduced or eliminated.

Repeated approval of the same type of medically necessary treatment should reduce or eliminate future prior authorization burdens for similar care

No prior authorization disruption of continuity

Prior authorization could not be used to disrupt ongoing care for a chronic condition without a clear medical reason—continuity of care would be protected.

Prior authorization may not be used to disrupt continuity of care for chronic or ongoing conditions without clear medical justification

Generic drug quality standards

Generic drugs would be required to meet strong quality and safety standards equivalent to brand-name drugs, so patients can trust that generics work as well as the originals.

Ban unnecessary allergens

Pharmaceutical manufacturers could not include unnecessary allergens or harmful additives in drug formulations when safer alternatives are available.

Supply chain traceability

The pharmaceutical supply chain would be required to have full traceability—so when contamination or counterfeiting is discovered, affected products can be traced and removed quickly.

National rehab standards

All rehabilitation facilities and programs would be required to meet nationally consistent standards for staffing, safety, and treatment quality.

Evidence-based rehab required

Rehabilitation treatment must be grounded in approaches with proven effectiveness—not practices that lack evidence or have been shown to cause harm.

Ban abusive rehab practices

Abusive practices in rehabilitation settings—including coercion, humiliation, and physically unsafe methods—would be explicitly prohibited and subject to enforcement.

Rehab transparency

Rehabilitation facilities would be required to publicly report on their ownership, outcomes, and treatment approaches so patients can make informed choices.

Accessible rehab treatment

Rehabilitation treatment must be made accessible to people regardless of income, location, or disability status—barriers that prevent people from accessing recovery would be addressed.

Rehab oversight and audits

Regular independent audits and oversight of rehabilitation programs would ensure ongoing compliance with safety and quality standards.

Expand voluntary treatment

Voluntary treatment options would be expanded so people seeking help can access rehabilitation without being required to enter coercive or institutional settings.

Increase funding for neglected conditions

Federal healthcare funding would be required to increase investment in neglected conditions, medications, and populations that have received less attention than their medical burden warrants.

Public healthcare and research policy must increase funding for neglected conditions medications and treatment gaps that lack commercial incentives but have significant public-health impact

Priority for stigmatized conditions

Research priorities would specifically include conditions that are stigmatized, commercially unattractive, or primarily affecting vulnerable populations—where market incentives alone will never drive adequate investment.

Research priorities should include stigmatized or less commercially attractive conditions including sexually transmitted infections chronic conditions and under-studied medication needs

Resist commercial research bias

Dedicated federal funding would support research into medications and treatments serving small patient populations or communities where there has historically been little commercial interest.

Healthcare governance should not allow commercial buzz or market hype to determine research priority at the expense of real public-health need

Broad prescription access required

Drug coverage systems must include broad access to the medications patients need—formularies (lists of covered drugs) cannot be used as hidden tools to effectively deny prescriptions.

Drug coverage systems must include broad access to medically necessary prescriptions and may not use formularies as hidden denial systems

Fast formulary exception pathways

When a patient needs a drug not on the standard formulary, there must be a fast and meaningful exception process so individual medical need is not overridden by a blanket list.

Patients must have fast and meaningful exception pathways when formulary restrictions conflict with individualized medical need

No harmful step-therapy loops

Coverage systems cannot require patients to try and fail on multiple drugs before accessing the treatment their doctor recommends, when doing so causes medical harm.

Coverage systems may not force repeated medication failure or step-therapy loops where doing so is medically harmful or unreasonable

Coverage for neglected condition medications

Coverage for medications must include drugs for conditions that are underfunded or neglected by commercial markets, where evidence supports their medical necessity.

Coverage for medications should include neglected or underfunded conditions where evidence supports medical necessity and public health importance

Controlled substance quotas ensure access

Federal production quotas for controlled medications must be set at levels that ensure patients with valid prescriptions can actually get them—not create artificial shortages.

Production quotas and regulatory limits on controlled medications must be set at levels that ensure reliable patient access to medically necessary treatment and may not create artificial shortages

No artificial medication shortages

Regulatory rules cannot restrict the supply of approved medications in ways that prevent patients from filling their prescriptions in a timely manner.

Regulatory systems may not restrict supply of approved medications in ways that prevent patients with valid prescriptions from obtaining treatment in a timely manner

Quotas based on real-world demand

Quotas for controlled substances must be based on actual real-world prescribing data and medical demand, not static limits set without regard to patient need.

Controlled substance quotas must be based on real-world medical demand prescribing data and public health needs rather than static limits or overly conservative projections

Rapid response to medication shortages

When shortages of controlled medications occur, regulators must act quickly to adjust supply chains and quotas to restore patient access.

When shortages of controlled medications occur regulators must act rapidly to adjust quotas supply chains and distribution to restore access

No geographic medication access restrictions

Patients must be able to fill prescriptions for controlled medications without encountering geographic or pharmacy access barriers that vary unfairly by region.

Patients must be able to access prescribed controlled medications without unreasonable geographic pharmacy or supply restrictions that vary by region

Balanced access expansion with safeguards

Expanding access to controlled medications would be paired with evidence-based prescribing guidelines and monitoring for misuse—protecting both access and safety.

Expansion of access to controlled medications must be paired with evidence-based prescribing guidelines monitoring for misuse and safeguards against diversion without restricting legitimate care

No patient-uncontrolled treatment disruption

Patients in ongoing treatment with controlled medications cannot have their care disrupted due to supply shortages, quota limits, or administrative barriers outside their control.

Patients receiving ongoing treatment with controlled medications may not have care disrupted due to supply shortages quota limits or administrative barriers beyond their control

Coverage must be evidence-based

Coverage decisions must be grounded in evidence-based medicine—not cost-cutting practices dressed up as clinical criteria.

Protect from partisan interference

Medical coverage standards must be set by scientific and clinical evidence, free from political or ideological interference.

Minimum service levels

All health plans would be required to meet minimum levels of service and access, so people can actually use the coverage they have.

Maximum wait times

Health plans would be held to maximum wait time standards for appointments and services, so covered care is available within a reasonable time.

Strict maximum response timelines

Coverage and prior authorization decisions must be made within legally required time limits, so patients are not left in limbo waiting for decisions.

Healthcare coverage decisions and prior authorization determinations must meet strict maximum response timelines

Accelerated urgent decision timelines

When a coverage decision involves urgent care, it must be made fast enough to prevent harm—urgency must shorten the decision timeline.

Urgent and emergency-related coverage determinations must be made on accelerated timelines sufficient to prevent medical harm

Presumptive approval if timelines missed

If a coverage decision is not made within the required timeframe, the requested care would be automatically approved unless narrow, defined exceptions apply.

If a coverage decision is not made within required timelines the requested care should be presumptively approved unless narrowly defined exceptions apply

No delay as denial strategy

Intentional administrative delay—dragging out decisions to avoid paying for care or to frustrate patients—would be prohibited and subject to enforcement.

Administrative delay may not be used as a strategy to avoid payment or discourage medically necessary care

Full transparency of evidence

The evidence base used to make coverage decisions must be fully transparent and publicly accessible, so patients and providers can understand why coverage rules are what they are.

Publish dissenting opinions

When there is genuine scientific disagreement about coverage criteria, dissenting expert opinions would be published and made part of the public record.

Independent audit systems

Independent audit systems would regularly review whether coverage decisions are actually being made according to the stated standards.

Treat addiction as medical condition

Addiction would be treated as a medical condition in coverage and clinical standards—not a moral failing—with treatment held to the same standards as any other chronic disease.

Harm reduction strategies

Harm reduction strategies—approaches that reduce the health risks of drug use without requiring abstinence—would be treated as valid evidence-based medical interventions.

Fund comprehensive supplement research through NCCIH

The NIH would fund rigorous, independent, placebo-controlled research on widely used dietary supplements to establish what they actually do and do not do.

The NIH National Center for Complementary and Integrative Health (NCCIH) must be funded to conduct rigorous, placebo-controlled, head-to-head trials of widely used dietary supplements. The current evidence base for the majority of commercially sold supplements is inadequate: the Dietary Supplement Health and Education Act of 1994 (DSHEA) removed the requirement for pre-market safety and efficacy review, meaning that most supplements on the market have never been tested in controlled clinical trials. NCCIH must have dedicated funding to close this gap, prioritizing supplements with wide public use, plausible mechanisms of action, and existing preliminary evidence — including vitamin D, magnesium, omega-3 fatty acids, melatonin, probiotics, and herbal preparations with traditional use histories.

Reform supplement labeling to reflect actual evidence

Supplement labels would have to accurately reflect what the science actually shows, not just what manufacturers are allowed to imply under the current weak labeling rules.

Supplement labels must accurately reflect the quality and weight of evidence for any claimed health benefit. The current FTC/FDA framework allows structure-function claims (e.g., "supports immune health") without requiring proof of efficacy, creating a marketplace where marketing language outpaces evidence. Labels must include standardized evidence quality ratings (e.g., Strong Evidence / Preliminary Evidence / Traditional Use / No Clinical Evidence), known drug interactions, populations for whom the supplement is contraindicated or requires medical supervision, and whether the claim has been evaluated in randomized controlled trials. The FDA must develop and enforce a mandatory evidence disclosure framework that applies to all supplements regardless of the specificity of their health claims.

Require independent laboratory testing and quality certification for all supplements

Supplements sold in the U.S. would be required to undergo independent laboratory testing to confirm they actually contain what the label says, at the stated dose.

Supplements sold in the United States are not required to undergo pre-market testing to confirm that they contain what the label states. Third-party testing programs (NSF International, USP, ConsumerLab) fill part of this gap voluntarily, but participation is optional. FDA manufacturing standards (21 CFR Part 111) require Good Manufacturing Practices but have faced chronic under-enforcement. All dietary supplements must be required to obtain third-party quality certification confirming identity, potency, purity, and the absence of contaminants and undisclosed active ingredients before they may be sold in interstate commerce. Manufacturers must make lab testing results publicly available. FDA must have funding and staffing to audit and enforce these requirements.

Establish minimum quality standards for supplement manufacturing

Manufacturing standards for dietary supplements would be strengthened and consistently enforced, including for imported products that currently face minimal scrutiny.

Good Manufacturing Practice (GMP) standards for dietary supplements must be strengthened, fully funded for enforcement, and applied consistently to domestic manufacturers and importers alike. Current GMP standards under 21 CFR Part 111 set baseline requirements but are inconsistently enforced due to FDA staffing and resource constraints. Minimum quality standards must include: required testing of every production batch for identity and potency; mandatory contamination screening; traceability requirements for all ingredients; and penalties for non-compliance that are sufficient to deter violations rather than represent a cost-of-doing-business calculation. Imported supplements must meet equivalent standards as a condition of entry.

Make adverse event reporting for supplements mandatory

Reporting of adverse events—health problems caused by supplements—would be made mandatory for healthcare providers, not just strongly encouraged, so dangerous products can be identified faster.

Under DSHEA 1994, adverse event reporting for dietary supplements is largely voluntary for consumers and healthcare providers; manufacturers are required to submit serious adverse event reports but face weak enforcement. This produces a surveillance system that dramatically underestimates supplement-related harms. Mandatory reporting of supplement adverse events — from both manufacturers and healthcare providers — must be required, with standardized reporting requirements, dedicated FDA tracking infrastructure, and public disclosure of aggregate safety data by supplement and ingredient. A searchable, publicly accessible adverse event database for supplements, analogous to FDA MedWatch for pharmaceuticals, must be created and maintained. Data from mandatory reporting must be used to trigger safety reviews and regulatory action.

Create a national, publicly accessible supplement safety and evidence database

A publicly accessible federal database of all marketed supplements, including safety data and the actual evidence for each claimed benefit, would be created and maintained.

A comprehensive, publicly accessible, plain-language database must be created and maintained by a federal agency (FDA, NIH, or jointly) covering all marketed dietary supplements. Each supplement entry must include: a summary of available evidence on efficacy for each claimed use; known safety concerns, adverse effects, and upper tolerable limits; documented drug-nutrient interactions; population-specific cautions (pregnancy, pediatric, elderly, immunocompromised); evidence quality rating; and links to underlying research. The database must be updated continuously as new evidence emerges, must be freely accessible to consumers and clinicians, and must serve as the federal government's primary tool for combating supplement misinformation. AI-assisted search and plain-language summaries must make the database accessible to non-specialist users.

Fund crowdsourced safety surveillance for supplements using patient-reported outcomes

A federally funded crowdsourced safety surveillance system would track patient-reported problems with supplements across a market too large for the FDA to monitor alone.

The supplement market is too large and diverse for FDA surveillance alone to track. A federally funded, peer-reviewed crowdsourced safety surveillance system — modeled on successful pharmacovigilance programs — must be established to collect and analyze patient-reported outcomes for dietary supplements. This system must: make submission accessible via web and mobile; require minimal entry barriers for consumers; apply statistical methods to identify safety signals from aggregate data; link with mandatory adverse event reports and emergency department data; and publish all findings in a form accessible to the public and clinicians. Algorithms for signal detection must be transparent and subject to independent methodological review.

Require pre-market safety notification for new supplement ingredients

Manufacturers introducing a genuinely new supplement ingredient would be required to notify the FDA and demonstrate it is safe before selling it—currently this notification requirement is poorly enforced.

DSHEA 1994 allows manufacturers to market supplements containing ingredients "new" to the market only if they notify FDA 75 days in advance — but this notification requirement is poorly enforced and does not require proof of safety. The result is that novel botanical ingredients, high-dose isolated compounds, and synthetic derivatives of natural substances can reach consumers with minimal prior safety evaluation. Pre-market safety notification requirements must be strengthened to require: documentation of the proposed daily dose and intended use; any available toxicological data; evidence of safe use history where applicable; and a mandatory FDA response period with authority to require additional safety data before marketing. The threshold for "new dietary ingredient" status must be clearly defined and enforced.

Combat supplement misinformation through accessible public evidence resources

The federal government would invest in public education resources to help people evaluate supplement claims critically and understand the difference between marketing and evidence.

The supplement market is saturated with misleading claims, pseudoscientific marketing, and deliberate exploitation of consumer confusion about evidence. The federal government must actively counter misinformation by making real evidence widely accessible, well-designed, and prominently promoted. The FDA, NIH NCCIH, and FTC must jointly fund and maintain consumer-facing resources that translate supplement evidence into plain language, correct common myths with specific citations, and provide practical guidance for consumers who use or are considering supplements. These resources must be prominently promoted in healthcare settings. Clinicians must have access to decision-support tools that integrate supplement-drug interaction data into standard prescribing workflows.

Require disclosure of commercial funding in supplement research and restrict use of industry-funded studies in federal guidance

Industry-funded supplement research would be required to be disclosed and independently replicated before it could be used to shape federal dietary guidance.

Industry-funded supplement research is subject to the same commercial bias documented in pharmaceutical research: funded studies are significantly more likely to produce positive results for the funder's product. All supplement research published in peer-reviewed journals must require full disclosure of commercial funding, author financial relationships with manufacturers, and any manufacturer involvement in study design, data access, or manuscript review. Federal dietary guidance, FDA safety determinations, and NIH evidence reviews must explicitly account for funding source in evidence quality assessments. Industry-funded studies that have not been independently replicated must be weighted accordingly in federal guidance documents and may not serve as primary evidence for safety or efficacy determinations.

Telemedicine without regional restriction

Telemedicine services would be available to patients everywhere in the country, without being limited by state lines or regional insurance restrictions.

Telemedicine as access equalizer

Telehealth would be treated as an access tool for people in rural areas, those with disabilities, and others who face barriers to in-person care—not as a secondary or lesser form of treatment.

Streamlined new treatment approvals

Approvals and clinical trials for new treatments would be streamlined and better funded to move promising treatments to patients faster.

Approvals and trials for new treatments funded and streamlined

Regulate transition-state coverage systems

Until the U.S. fully implements universal healthcare, all existing coverage systems would be regulated to move closer to universal standards—no rollbacks allowed during the transition.

Until universal single-payer healthcare is implemented all healthcare coverage systems must be regulated to protect patients from denial delay fragmentation and extractive practices

Immediate improvement without delay

Healthcare reforms during any transition period must improve care immediately rather than weakening existing protections while waiting for a future system to arrive.

Transition-state healthcare reform must be designed to improve care immediately without weakening or delaying the long-term goal of universal single-payer healthcare

Mandate maternal mortality review and racial equity reporting

Every state would be required to maintain a maternal mortality review committee that investigates all pregnancy-related deaths, with results reported publicly and broken down by race to make disparities visible.

Every state must maintain a maternal mortality review committee with authority to investigate all pregnancy-related deaths; results must be reported publicly in race-disaggregated form and used to develop targeted interventions addressing the disproportionately high maternal mortality rates among Black and Indigenous women.

Require coverage of doula, midwifery, and comprehensive postpartum care

Coverage would include doulas, certified midwives, and at least 12 months of postpartum care—expanding beyond the current standard of one visit six weeks after delivery.

Coverage systems must include perinatal support services — doulas, certified midwives, and at minimum 12 months of postpartum follow-up care — and may not limit reimbursement for community health workers providing maternal support in underserved or high-mortality communities.

Require coverage of post-acute sequelae of infectious disease

Post-viral conditions like Long COVID would be classified as chronic conditions requiring ongoing medical care and coverage, not dismissed as temporary or unverifiable.

Coverage systems must classify post-acute sequelae of infectious disease — including Long COVID and post-viral syndromes — as chronic conditions requiring ongoing specialist care, occupational and physical therapy, cognitive rehabilitation, and care coordination; coverage may not be denied on grounds that the underlying acute infection resolved.

Cover long-term disability management and return-to-work support

People with chronic post-viral conditions would be covered for occupational therapy, assistive devices, workplace accommodations, and vocational rehabilitation to help them return to work and daily life.

Coverage systems must include occupational therapy, assistive technology, workplace accommodation support, and vocational rehabilitation for individuals with chronic disabling conditions; coverage may not be terminated solely because a condition is deemed permanent rather than treatable.

Include dental care in the mandatory coverage floor

Dental care—including cleanings, fillings, gum disease treatment, and oral surgery—would be part of the required coverage floor, not an optional add-on.

Traditional Medicare would be required to cover dental care for the first time, including preventive cleanings, fillings, root canals, and dentures. Today, most seniors must pay entirely out of pocket for dental care.

Coverage systems must include comprehensive dental care — preventive, restorative, periodontal, and oral surgery services — as part of the mandatory floor of medically necessary care; dental care may not be segregated into a separate lower tier with higher cost-sharing or narrower networks than medical coverage.

Include vision care in the mandatory coverage floor

Vision care—including routine eye exams and corrective lenses—would be part of the required coverage floor, not a separate optional benefit.

Coverage systems must include comprehensive vision care — routine eye exams, corrective lenses, and treatment of conditions affecting vision — as part of the mandatory floor of medically necessary care; vision care may not be excluded or severely limited relative to other medical coverage.

Guarantee healthcare for incarcerated individuals equivalent to community standards of care

People who are incarcerated have a constitutional right to healthcare that meets community standards of care. Jails and prisons must provide timely access to medical treatment, mental health care, and prescription medications.

Every person in state or federal custody has a constitutional right to healthcare meeting community standards; correctional facilities must provide timely access to medical, dental, mental health, and substance use treatment; healthcare in detention may not be rationed as a cost-control measure, used as a disciplinary tool, or delivered through private contractors exempt from public accountability and judicial review.

Establish coverage and preparedness standards for climate-related health conditions

Health coverage systems would be required to cover conditions caused or worsened by climate change, including heat-related illness, respiratory disease from air pollution, and diseases spread by insects moving into new regions as temperatures rise.

Coverage systems must include treatment for climate-related health conditions — heat illness, expanded-range vector-borne diseases, air quality-driven respiratory conditions, and mental health impacts of climate disasters — and public health agencies must develop preparedness protocols for climate-driven health emergencies with priority attention to communities bearing disproportionate climate burdens.

Establish a general right to access investigational treatments under physician supervision

Adult patients who have tried all approved treatments—or for whom no approved treatment exists—would have the right to access investigational treatments under a licensed physician's supervision.

Any adult patient who has exhausted or has documented contraindications to all standard approved treatments, or for whom no approved treatment exists, has the right to access investigational treatments under a licensed physician's supervision within an approved protocol. A qualifying condition includes: a serious, chronic, or disabling condition; a condition causing severe, persistent pain or physical suffering; a condition causing severe mental or emotional distress that substantially impairs daily functioning; or a condition significantly reducing quality of life. This framework is not limited to terminal or life-threatening illness. The framework protects patients, physicians, and the government's regulatory authority simultaneously and must not be interpreted to weaken FDA approval standards or create a path to unregulated commercial access.

Require licensed physician oversight for all investigational treatment access

All access to investigational treatments under this framework would require a licensed physician to order, oversee, and monitor the treatment throughout the process.

Access to investigational treatments under this framework requires that a licensed physician order, administer or directly supervise the administration of, and monitor all treatment. Self-administration, wellness-clinic administration, and lay or unlicensed facilitation are prohibited under this framework. Physicians must document clinical rationale, monitor for adverse effects, and maintain records that feed the national outcomes database.

Require informed consent, independent evaluation, and second opinion

Before trying an investigational treatment, patients must receive full written informed consent in plain language, an independent medical evaluation, and a second physician opinion.

Before any investigational treatment under this framework, patients must: (a) receive full written informed consent in plain language disclosing all known and potential risks, the investigational status of the treatment, and available alternatives; (b) undergo an independent clinical evaluation confirming medical eligibility; and (c) obtain a second opinion from a physician not affiliated with the treating practice. Consent and evaluation records must be retained and are part of the mandatory outcome data submission.

Define patient eligibility criteria

To qualify for investigational treatment access, a patient must have a confirmed diagnosis from a licensed physician and have exhausted or be unable to use approved treatments.

Patient eligibility for investigational treatment access requires at minimum: (a) a confirmed diagnosis by a licensed physician of a qualifying condition — including a serious, chronic, or disabling condition; a condition causing severe, persistent pain or physical suffering; a condition causing severe mental or emotional distress that substantially impairs daily functioning; or a condition significantly reducing quality of life; (b) documentation that all approved treatments have been tried and failed, are contraindicated, or that no approved treatment exists; (c) a clinical finding that the potential benefit outweighs known risk given the patient's condition; and (d) capacity to provide informed consent, or, for patients lacking capacity, appropriate legal authorization. Eligibility criteria must be reviewed and updated by an independent medical board on a rolling basis as evidence develops.

Mandate research data contribution from all investigational treatment access

Every use of investigational treatment would contribute anonymized outcome data to a national research database, turning individual access into evidence that helps future patients.

Every instance of investigational treatment access under this framework constitutes a contribution to the national research base. Treating physicians must submit standardized anonymized outcome data — including dosing, adverse events, clinical response, and follow-up — to the national public research database within a defined period. Failure to submit required data terminates the treating physician's participation privileges. The data mandate is the mechanism by which patient access generates societal benefit and justifies the access framework.

Establish strict patient data privacy and security standards

All data submitted to the national investigational treatment database would be de-identified and protected to the highest privacy standards before submission.

All data submitted to the national research database under this framework must be fully de-identified before submission, using standards at minimum equivalent to HIPAA Safe Harbor requirements. Data infrastructure must use end-to-end encryption, strict access controls limited to credentialed researchers, and regular independent security audits. No commercial entity may purchase, license, or access the underlying patient data. Aggregate and anonymized findings may be published; no re-identification attempts are permitted, and violations constitute a federal offense.

Create a national public research database for investigational treatment outcomes

A publicly searchable national database of anonymized outcomes from investigational treatments would be created, so researchers, patients, and doctors can learn from real-world results.

The federal government must establish and maintain a publicly accessible, searchable national database of anonymized outcome data from all investigational treatment access under this framework. The database must include aggregate data by treatment type, condition, dosing, adverse event rate, and clinical response. All data is public property, available to researchers, institutions, and the public at no cost. The database is governed by an independent scientific board with no commercial affiliations and is subject to annual public reporting on data quality, completeness, and research use.

Protect physicians acting in good faith under approved protocols

Doctors who follow all required protocols when administering an investigational treatment would be protected from professional discipline and civil liability.

A licensed physician who administers an investigational treatment in compliance with this framework — including all documentation, consent, evaluation, and data submission requirements — is protected from: (a) criminal prosecution solely on the basis of administering a controlled or investigational substance within the protocol; (b) professional licensing action solely on the basis of protocol-compliant treatment; and (c) civil liability beyond the standard of care applicable to licensed physicians generally. These protections are contingent on full protocol compliance and do not extend to negligence, fraud, or violations of the framework's requirements.

Preserve government regulatory authority; no commercial access created

This framework creates a medically supervised access path—it does not create a commercial market for unapproved drugs, and the government's authority to regulate drugs is fully preserved.

This framework creates a supervised medical access path and does not: (a) create any right to unregulated commercial access to investigational substances; (b) establish a precedent for or path to market approval of any substance; (c) limit FDA authority to restrict, condition, or revoke access to any substance; (d) create any obligation on insurers to cover investigational treatments; or (e) constrain DEA scheduling authority except as required by the evidence-based rescheduling process in HLT-RTT-010. Regulatory agencies retain full authority to suspend or modify the framework if patient safety evidence warrants it.

Require evidence-based, apolitical rescheduling review for substances with established safety profiles

The DEA and FDA would be required to conduct mandatory evidence-based reviews of drug scheduling classifications for substances with established safety profiles, keeping scheduling decisions grounded in science rather than politics.

The DEA and FDA must conduct a mandatory, evidence-based review of the scheduling classification of any substance that: (a) has an established safety profile demonstrated in peer-reviewed clinical research; (b) has shown evidence of medical utility in two or more independent peer-reviewed trials; and (c) is classified in a schedule that currently prohibits or severely restricts research. Scheduling decisions must be made on scientific and public-health criteria and are not subject to political override. Substances that pass review must be rescheduled to allow supervised medical access and expanded research. This provision specifically applies to psilocybin, MDMA, ketamine, cannabis, and any other substance that meets these criteria.

Expand FDA expanded access and streamline compassionate use pathways

The FDA's expanded access program would be reformed to set a 30-day decision deadline, require written justification for denials, and streamline the application process so patients can access it without a lawyer.

The FDA Expanded Access program must be reformed to: (a) set a 30-day maximum decision timeline for individual patient access requests; (b) require written justification for any denial; (c) allow treating physicians to apply directly without requiring manufacturer cooperation where manufacturer refusal is not clinically justified; (d) extend program scope beyond terminal illness to serious conditions where no approved alternatives exist; and (e) require that all expanded access outcomes are submitted to the national research database. Manufacturers may not use expanded access data as the sole basis for commercial approval without independent clinical trials.

Prohibit exploitation of right-to-try patients

No manufacturer or clinic could charge patients more than actual cost recovery for investigational treatments. Requiring patients to waive their right to sue as a condition of access would be prohibited.

No manufacturer, clinic, or provider may charge more than reasonable cost-recovery for investigational treatments accessed under this framework. Manufacturers may not require waivers of future legal claims as a condition of access. Patients may not be charged for adverse event treatment that results from protocol-compliant investigational access. Any entity found to be exploiting the framework for commercial profit without delivering genuine medical benefit is subject to immediate suspension from the program and civil penalties. The framework is a patient protection mechanism, not a commercial channel.

Establish a federal minimum for public research investment

Federal investment in public research—through NIH, NSF, CDC, and similar agencies—would be treated as a guaranteed baseline public good, protected from arbitrary cuts.

Federal investment in publicly funded research — including NIH, NSF, CDC, and agency research programs — must be treated as a baseline public good, not a discretionary line item subject to annual political negotiation. Federal research spending must be set at a minimum floor tied to a percentage of GDP, reviewed upward every five years, and immune from across-the-board discretionary cuts. The goal is to reach parity with leading research nations and to double NIH funding over a ten-year horizon from current baselines.

Protect research independence from commercial interference

Federally funded research must be free from commercial control. No company could hold exclusive rights over study design, data access, or publication of publicly funded work.

Federally funded research must be conducted free from commercial control over study design, data access, publication rights, and result interpretation. No commercial entity may hold rights that allow it to suppress, delay, or selectively publish federally funded research results. Grant-funded researchers must disclose all industry financial relationships annually. Research institutions receiving federal funding must implement and enforce firewalls between commercial contract research and publicly funded research programs.

Mandate open access for all federally funded research

All research funded with public dollars must be published openly and available to anyone at no cost, within twelve months of publication.

All research funded in whole or in part by federal dollars must be published in open-access formats, available to the public at no cost, within twelve months of publication (or immediately upon publication for grant conditions permitting). This applies regardless of the journal or venue chosen by the researchers. Data underlying published federally funded research must be deposited in publicly accessible repositories with sufficient documentation for independent replication. Paywalled access to publicly funded research is a public subsidy for private publishers and must end.

Prioritize neglected and under-commercially-funded research areas

Federal research priorities must actively counter market bias by directing funding toward neglected conditions, rare diseases, and populations that the commercial market underserves.

Federal research priority-setting must affirmatively counteract market bias toward high-profit conditions and treatments. Priority areas that must receive proportional or enhanced public research investment include: rare diseases, pediatric conditions, mental health, addiction, stigmatized conditions, neglected tropical diseases, antimicrobial resistance, conditions disproportionately affecting low-income and minority populations, and treatment modalities (including behavioral, psychedelic, and non-pharmaceutical interventions) with genuine evidence but no commercial development pathway. Priority allocation must be set by an independent scientific board, not industry lobbyists.

Fund research replication and negative results reporting

Federal funding would include a dedicated allocation for replication studies—independently re-running key findings—to address the reproducibility crisis in science that has allowed bad results to influence public health policy.

The reproducibility crisis in science is a public health problem. Federal research funding must include a dedicated allocation for replication studies — independently re-running key results from prior research — and must require funded journals and repositories to accept and publish negative results (studies where the intervention showed no effect) without discrimination. Publication bias toward positive results distorts the evidence base that clinicians, policymakers, and patients depend on.

Establish independent scientific advisory bodies free from political appointment pressure

Federal scientific advisory committees—including FDA and CDC panels—must be composed of scientists selected on merit and expertise, free from political appointment pressure.

Federal scientific advisory committees — including FDA advisory panels, NIH study sections, and CDC advisory bodies — must be composed of credentialed scientists selected on merit. Advisory committee members must disclose and recuse for all relevant financial and institutional conflicts of interest. No advisory committee member may be removed by political appointees for scientific positions taken in good faith. Scientific agencies must publish dissenting advisory opinions when final agency decisions diverge from advisory committee recommendations.

Fund a national research infrastructure for emerging and investigational therapies

A national research infrastructure with dedicated funding would support clinical investigation of promising under-studied therapies, including psychedelic-assisted treatments and other approaches that market forces have failed to fund.

Federal research infrastructure must include dedicated programs and funding for clinical investigation of promising but under-studied therapies — including psychedelic-assisted therapy, novel psychiatric interventions, regenerative medicine, and treatments with preliminary evidence but insufficient commercial development incentive. This infrastructure must include: grant programs for Phase 1–3 clinical trials; a clinical trial network with geographic distribution; training programs for researchers in these areas; and a public registry of all active and completed investigational treatment trials.

Protect scientific whistleblowers and dissenting researchers

Researchers who report misconduct, data manipulation, or commercial interference in federally funded research would be protected as whistleblowers against retaliation.

Researchers who report research misconduct, data manipulation, suppression of results, or inappropriate commercial influence in federally funded research are protected whistleblowers. No grant, contract, or employment retaliation may be taken against a researcher for reporting in good faith. Scientific agencies must maintain independent, confidential channels for reporting misconduct. The integrity of the scientific enterprise is a public interest, and its protection is a government obligation.

Mandate NIH research funding proportional to disease burden for conditions disproportionately affecting women

Federal research funding for conditions that disproportionately affect women—including endometriosis, PCOS, and autoimmune diseases—would be proportional to how much those conditions affect people's lives, not based on historical neglect.

Federal research funding for conditions that disproportionately affect women — including endometriosis, polycystic ovary syndrome (PCOS), autoimmune diseases (which affect women at 2–3x the rate of men), female-pattern cardiovascular disease presentation, and menopause — must be allocated in proportion to disease burden, not commercial potential. The NIH Office of Research on Women's Health (ORWH) must be funded and empowered to audit research portfolios across all NIH institutes and enforce proportional investment. Underfunded areas must receive targeted supplemental grants.

Require inclusion of women in all federally funded clinical trials and enforce the 1993 NIH Revitalization Act

The 1993 law requiring women to be included in federally funded clinical trials would be actively enforced—not just on paper—so medical treatments are tested on women and not just extrapolated from male-only studies.

The NIH Revitalization Act of 1993 (Pub. L. 103-43) required women and minorities to be included in all NIH-funded clinical research. Thirty years later, compliance is inconsistent and enforcement mechanisms remain weak. All federally funded clinical trials must include women in numbers sufficient for sex-stratified analysis. Results must be reported disaggregated by sex and gender. Trials that fail to include adequate female representation must be flagged in grant renewal reviews and may have continued funding conditioned on compliance plans. The NIH ORWH must publish annual compliance reports.

Fund dedicated research programs for endometriosis, PCOS, and other chronically underfunded women's conditions

Dedicated federal research programs would finally address endometriosis, PCOS, and other chronically underfunded women's health conditions that cause severe suffering and have been ignored for decades.

Endometriosis affects an estimated 1 in 10 women of reproductive age, causes debilitating chronic pain, and contributes to infertility — yet receives less than $16 million annually in NIH research funding, compared to billions for conditions with equivalent or lower disease burden. PCOS, affecting up to 13% of women of reproductive age, is similarly underfunded. Dedicated research programs with protected multi-year funding must be established for endometriosis, PCOS, uterine fibroids, and other conditions where funding historically falls short of disease burden. These programs must fund basic science, clinical trials, diagnostic tools, and treatment development.

Establish a national research agenda for menopause and female aging

A national research agenda for menopause and female aging would be established, filling a striking gap given that menopause affects every woman who lives to middle age.

Menopause affects every woman who lives to middle age, yet research into menopause symptoms, long-term health consequences, and treatment options is strikingly thin. The Women's Health Initiative (1991–2002) was groundbreaking but limited in scope; the field has not kept pace with the needs of an aging female population. Federal research priorities must include: the long-term cardiovascular, bone, cognitive, and metabolic consequences of menopause; the safety and efficacy of hormone therapy across different formulations and delivery methods; non-hormonal interventions for menopause symptoms; and the impact of menopause timing and trajectory on overall healthy aging. ORWH must coordinate a national menopause research agenda across NIH institutes.

Fund research into maternal mental health and the perinatal period

Perinatal mental health conditions—including postpartum depression and anxiety, which affect up to 1 in 5 new parents—would receive dedicated federal research funding and improved clinical recognition.

Perinatal mood and anxiety disorders — including postpartum depression, postpartum anxiety, postpartum PTSD, and postpartum psychosis — affect up to 1 in 5 new mothers and are significantly underdiagnosed and undertreated. These conditions are the leading cause of maternal morbidity in high-income countries and have measurable negative effects on child development. Federal research funding must prioritize: screening tools and intervention studies; treatment protocols including medication safety during pregnancy and breastfeeding; structural and social risk factors including economic insecurity and partner violence; and long-term outcomes for both mothers and children. NIMH must designate perinatal mental health as a priority research area with protected funding.

Address the sex-based gap in cardiovascular disease research and clinical recognition

Research and clinical guidelines for cardiovascular disease in women would be updated to reflect that women often present with different symptoms than men, correcting decades of under-diagnosis.

Heart disease is the leading cause of death among women, yet cardiovascular research historically used male subjects as the default and male symptom presentation as the diagnostic standard. Women with heart attacks frequently present differently than men — less chest pain, more nausea, fatigue, and jaw pain — leading to missed diagnoses and delayed treatment. Women are less likely to be offered the same aggressive cardiovascular interventions as men with equivalent conditions. Federal research must fund: sex-disaggregated analysis of all cardiovascular trials; research into female-specific cardiovascular risk factors and presentations; training programs for clinicians on recognizing cardiovascular disease in women; and development of diagnostic tools calibrated for female physiology. All new cardiovascular treatment research receiving federal funding must include women in proportional numbers and analyze outcomes by sex.

Mandate inclusion of underrepresented populations in all federally funded clinical trials

All federally funded clinical trials would be required to include racial, ethnic, and gender minorities in numbers large enough to produce meaningful results for those communities.

All federally funded clinical trials must include racial, ethnic, sexual orientation, and gender identity minorities in numbers sufficient for subgroup analysis. Trials designed for broad clinical use that exclude or dramatically undersample minority populations produce evidence that may not generalize to those populations — meaning treatments approved primarily in white male populations may be less effective, differently dosed, or carry different risk profiles for other populations. NIH must require disaggregated results reporting by race, ethnicity, sex, age, and where relevant, sexual orientation and gender identity. Failure to meet inclusion requirements must trigger corrective action prior to grant renewal.

Fund dedicated research into Black maternal mortality and obstetric disparities

Dedicated federal funding would go toward understanding and reducing the alarming gap in pregnancy-related death rates between Black women and white women.

Black women in the United States die from pregnancy-related causes at approximately 2.6 times the rate of white women — a disparity that persists across income, education, and access to care. This is a national public health crisis that is not explained by individual risk factors alone and reflects systemic failures in how care is delivered to Black patients. NIMHD and NICHD must fund research into: the specific mechanisms driving obstetric racial disparities; the role of provider bias and institutional racism in care quality; structural interventions including doula access and community health worker programs; and the effectiveness of implicit bias training and anti-racism protocols in clinical settings. Research findings must directly inform training requirements and clinical guidelines.

Fund LGBTQ+ health disparities research and require disaggregated data collection

Research into LGBTQ+ health disparities would be funded and expanded, and federal health data collection would be required to include sexual orientation and gender identity.

LGBTQ+ populations face documented health disparities across mental health, substance use, HIV/STI risk, cancer screening, and healthcare access — yet remain systematically excluded from most large-scale health research because surveys and clinical data systems fail to collect sexual orientation and gender identity (SOGI) data. All federally funded health research and federal health surveys must collect and report SOGI data using validated, inclusive instruments. NIMHD must fund research into LGBTQ+ health disparities, with particular attention to the intersection of minority stress theory with physical health outcomes, healthcare avoidance due to discrimination, and the health effects of structural stigma. Transgender health must be funded as a distinct research priority.

Fund research on Native American and Alaska Native health disparities and support tribal health sovereignty

Federal funding would increase for research into Native American and Alaska Native health disparities, with genuine respect for tribal sovereignty in health policy decisions.

American Indian and Alaska Native (AIAN) populations experience some of the worst health outcomes of any demographic group in the United States, including dramatically elevated rates of diabetes, cardiovascular disease, mental health conditions, and substance use disorders, alongside severely inadequate access to healthcare through the Indian Health Service (IHS). NIMHD must fund research into AIAN health disparities, in full partnership with tribal nations and organizations. Research must be conducted under community-based participatory research principles that center tribal sovereignty and benefit tribal communities. Research priorities must be set with tribal input, and findings must be returned to communities in accessible formats. Data sovereignty — the right of tribal nations to control research data about their members — must be respected and codified in research agreements.

Require disaggregated data for Asian American and Pacific Islander populations

Asian Americans and Pacific Islanders would no longer be lumped together in health data—separate data collection would make health disparities across these diverse communities visible.

Asian Americans and Pacific Islanders are routinely treated as a monolithic demographic in health data, obscuring dramatic disparities between subgroups. Hmong, Cambodian, and Laotian Americans have drastically higher rates of certain cancers, diabetes, and mental health conditions than Chinese or Indian Americans, yet aggregate "Asian" statistics erase these disparities. All federal health data collection and research must collect and report disaggregated data for Asian American and Pacific Islander subgroups. NIMHD must fund research into health disparities specific to underserved AAPI subgroups, with particular attention to refugee and immigrant communities, which face compounded barriers including language access, cultural competency gaps, and immigration-related stress.

Fund research into the social determinants of health and structural drivers of health disparities

Federal research would increase into the structural factors—housing, income, education, neighborhood conditions—that drive health disparities more than individual behavior or genetics.

Health disparities are not primarily the result of individual behavior or genetic differences — they are driven by structural conditions including housing, income, neighborhood environment, access to healthy food, educational opportunity, exposure to environmental hazards, and historical patterns of segregation and disinvestment. Clinical medicine alone cannot close disparity gaps when structural conditions produce those gaps. Federal research must fund rigorous investigation of social determinants of health (SDOH), including: the quantified health effects of poverty, housing instability, food insecurity, and environmental racism; natural experiments from policy changes; intervention studies testing structural solutions; and implementation research on integrating SDOH screening and intervention into clinical practice. NIMHD must coordinate an interagency research agenda on SDOH with HHS, EPA, HUD, and USDA.

Fund federal research into ultra-processed food consumption and chronic disease

The federal government would fund rigorous scientific research into how ultra-processed foods—industrial food products loaded with additives—contribute to chronic disease.

Ultra-processed foods — defined by the NOVA classification system as industrial formulations containing ingredients not used in home cooking, including additives, emulsifiers, flavor enhancers, and artificial colors — now account for more than half of calories consumed by Americans and are associated in observational studies with increased rates of obesity, type 2 diabetes, cardiovascular disease, depression, and all-cause mortality. The evidence base is growing but currently relies heavily on observational cohort data; randomized controlled trials are rare due to their methodological complexity. NIH and USDA must fund rigorous clinical trials and mechanistic research into the health effects of ultra-processed food consumption, including dose-response relationships, specific food processing attributes driving harm, and population-level intervention strategies. Research must be independent of food industry funding.

Require independence in the Dietary Guidelines for Americans process

The committee that writes the federal Dietary Guidelines would be required to operate independently of the food industry, whose funding has historically influenced nutrition policy in ways that serve commercial interests over public health.

The Dietary Guidelines for Americans, published jointly by HHS and USDA every five years, are the basis for federal nutrition policy including school lunches, SNAP, military feeding, and WIC. The process for developing these guidelines has documented conflicts of interest: members of the Dietary Guidelines Advisory Committee have financial ties to the food and beverage industry, industry-funded research is weighted alongside independent research in evidence reviews, and industry representatives participate in stakeholder comment processes in ways that have been shown to influence guideline language. The Dietary Guidelines process must be reformed to: exclude from the Advisory Committee any member with a financial relationship to food industry entities within the prior five years; explicitly down-weight industry-funded research in evidence reviews; require that any industry-funded study used in the evidence base has been independently replicated; and publish all conflict of interest disclosures prominently.

Fund research into food deserts, dietary access, and structural drivers of poor nutrition

Federal research funding would go toward understanding how structural factors like food deserts, poverty, and geography drive poor nutrition outcomes that cannot be solved by individual behavior change alone.

Dietary quality in the United States is strongly predicted by income, geography, and race — structural factors that individual behavior change alone cannot address. Food deserts (areas with inadequate access to affordable fresh food) affect tens of millions of Americans, predominantly in low-income and minority communities. USDA and NIH must fund research into: the causal relationships between food environment and dietary intake; the effectiveness of interventions to increase access to nutritious food in underserved communities (including SNAP incentive programs, mobile markets, urban agriculture, and corner store conversion programs); the role of food pricing, marketing, and retail availability in shaping population-level dietary patterns; and the economic returns on investment for food access interventions as preventive healthcare. Research must be conducted in partnership with affected communities and must produce actionable findings for policymakers.

Create a continuously updated National Nutrition Database grounded in independent research

The national nutrition database would be continuously updated, expanded, and grounded in independent research—making it a genuinely useful resource for patients, clinicians, and policymakers.

The United States maintains the USDA FoodData Central database and the USDA National Nutrient Database, both valuable but underutilized public resources. These databases must be expanded and updated continuously to reflect current research on food composition, bioavailability, and health effects. A national nutrition evidence portal — distinct from dietary guidelines — must integrate updated research findings on the health effects of specific foods, dietary patterns, and nutrients, with plain-language summaries accessible to the public, healthcare providers, and policymakers. All data underlying the portal must be based on independent or transparently conflict-of-interest-disclosed research. The portal must distinguish clearly between established findings, emerging evidence, and areas of genuine scientific uncertainty.

Fund longitudinal research on diet, mental health, energy, and quality of life

Long-term federal research would study how diet affects mental health, energy, cognitive function, and quality of life—areas currently underfunded relative to their importance.

The relationship between dietary patterns and mental health — including depression, anxiety, cognitive function, energy levels, and overall quality of life — is one of the most rapidly developing areas of nutrition science, with growing evidence that the gut-brain axis, microbiome composition, and dietary inflammation play significant roles in mood and cognitive outcomes. Yet this area receives a fraction of the research funding directed at dietary impacts on cardiovascular disease or cancer. NIH must fund longitudinal cohort studies and randomized dietary intervention trials examining the effects of dietary patterns — not single nutrients — on mental health outcomes, energy, sleep quality, cognitive performance, and patient-reported quality of life. Studies must include diverse populations and control for confounding variables. Findings must be integrated into clinical practice guidelines for mental health providers.

Require independent replication before industry-funded nutrition research informs federal policy

Before industry-funded nutrition research can inform federal dietary policy, it would be required to be independently replicated—preventing repeat historical examples of food industry science shaping public guidance.

The history of nutrition science is replete with examples of industry-funded research that shaped federal policy in ways that served commercial interests rather than public health — from the sugar industry's funding of research that blamed dietary fat for cardiovascular disease, to beverage industry funding of studies questioning the role of sugary drinks in obesity. This pattern is well-documented and ongoing. Any nutrition research funded in whole or in part by a food, beverage, or agricultural industry entity that is used to inform federal dietary guidelines, USDA programs, FDA labeling standards, or any other federal nutrition policy must first be independently replicated by a study with no industry funding. Federal agencies must maintain and publicly disclose the funding provenance of all research cited in nutrition policy documents.

Fund research into the microbiome and its role in health and disease

Federal funding would support rigorous research into the human microbiome and its role in health and disease—an emerging field with major implications for nutrition, immunity, and chronic disease.

The human microbiome — the community of trillions of microorganisms inhabiting the gut, skin, and other body systems — is among the most active frontiers in biomedical research, with emerging evidence linking microbiome composition to immune function, mental health, metabolic health, responses to medications, and risk of numerous chronic diseases. Diet is the primary modifiable driver of microbiome composition. NIH must maintain and expand the Human Microbiome Project and related research programs, with dedicated funding for: mechanistic studies linking microbiome composition to health outcomes; dietary intervention studies targeting microbiome modification; the role of antibiotic use in disrupting microbiome health across the lifespan; individual variation in microbiome response to dietary change; and the development of microbiome-based diagnostic and therapeutic tools. Research must be open-access and findings must be translated for clinical use.

Integrate nutrition into medical education and primary care practice

Nutrition education would be integrated into medical school and primary care practice, so physicians are equipped to counsel patients on diet—currently most receive fewer than 20 hours of nutrition training in medical school.

Most physicians receive fewer than twenty hours of nutrition education during medical school — an inadequate foundation for counseling patients on the diet-related chronic diseases that account for the majority of U.S. morbidity and healthcare expenditure. Federal research must fund studies on: the effectiveness of nutrition counseling interventions in primary care settings; models for integrating registered dietitians into primary care teams; the return on investment of nutrition-based interventions as preventive care; and optimal curriculum designs for increasing nutrition competency in medical, nursing, and allied health education. Findings must be used to develop federally supported curriculum guidelines for health professional education and to justify Medicare and Medicaid reimbursement for medical nutrition therapy across a broader range of diagnoses.

Fund development of vaccines for underserved infectious disease targets

Federal funding would go toward developing vaccines for infectious diseases—like STIs, tuberculosis, and malaria—where commercial incentives alone have failed to produce vaccines despite massive need.

Vaccine development for many high-burden infectious diseases has lagged far behind need due to inadequate commercial incentive — sexually transmitted infections including HSV-2 (herpes simplex virus type 2, affecting an estimated 11.9% of Americans aged 14–49), chlamydia, gonorrhea, and syphilis have no licensed vaccines despite enormous disease burden; improved influenza vaccines with broader strain coverage and longer-lasting protection remain underfunded; RSV vaccines for adults were only recently licensed after decades of inadequate public investment. Federal research investment must prioritize: development and clinical trials for STI vaccines with promising preliminary evidence; next-generation influenza vaccines with universal or broadly protective coverage; vaccine approaches for other common infections where development has stalled due to inadequate commercial incentive; and infrastructure for rapid vaccine platform development in response to emerging infectious disease threats. NIAID must receive dedicated funding for these programs independent of annual political negotiation.

Create a real-time, publicly accessible national vaccine safety surveillance database

A real-time, publicly accessible national vaccine safety database would be created, moving beyond the current passive reporting system that under-counts adverse events and is difficult for the public to use.

The Vaccine Adverse Event Reporting System (VAERS), jointly managed by CDC and FDA, is a passive surveillance system with significant limitations: reports are largely voluntary, cannot establish causation, are widely misunderstood by the public as documenting vaccine-caused adverse events, and are presented in formats that are not accessible to general audiences. These limitations have been actively exploited by vaccine-hesitancy advocates who cite VAERS report counts as evidence of harm. A modernized national vaccine safety surveillance system must: incorporate active surveillance through electronic health record linkage (building on the Vaccine Safety Datalink and BEST Initiative); present data in plain language that accurately communicates both what the data shows and its limitations; distinguish clearly between adverse events that occurred after vaccination and adverse events caused by vaccination; provide real-time public access to aggregate data in accessible formats; and be resourced for proactive communication in periods of heightened public concern.

Fund the largest independent vaccine safety studies ever conducted and publish all data publicly

The federal government would fund and publish the largest independent post-market vaccine safety studies ever conducted, providing solid evidence to support public confidence.

Public confidence in vaccine safety cannot be rebuilt by assertion alone. The federal government must commission, fund, and publish the largest independent post-market vaccine safety studies ever conducted, using active surveillance methodologies, electronic health record data, and rigorous epidemiological designs capable of detecting rare adverse events if they exist. Studies must be conducted by independent researchers with no financial ties to vaccine manufacturers. Complete datasets must be published in open-access formats with sufficient documentation for independent replication and analysis. This effort is not an admission that vaccines are unsafe — the existing evidence strongly supports their safety and efficacy — but a recognition that maximum transparency is required to restore and maintain the public trust that makes vaccination programs effective. All findings, including null results, must be published promptly.

Create a Vaccine Evidence Portal for public trust-building and plain-language communication

A permanent, publicly accessible Vaccine Evidence Portal would be established to communicate vaccine science clearly and honestly—answering real public questions with real evidence.

A federally funded, publicly accessible Vaccine Evidence Portal must be created as a permanent resource for vaccine science communication. The portal must provide: plain-language summaries of safety and efficacy evidence for all vaccines in the U.S. immunization schedule; explanations of how vaccines are tested, approved, and monitored; clear, honest descriptions of known and potential risks alongside the substantially greater risks of the diseases vaccines prevent; direct responses to common vaccine-related questions and misconceptions, with citations; a searchable database of underlying research; and evidence-based guidance for clinicians on vaccine communication with hesitant patients. The portal must be designed with health literacy principles, tested with representative public audiences, available in multiple languages, and updated continuously as evidence evolves. The portal must not be used as a promotional tool — it must be a neutral, credible, science-communication resource.

Ensure all evidence-based vaccines are covered without cost-sharing under universal healthcare

All vaccines recommended by the CDC's Advisory Committee on Immunization Practices would be covered without any cost-sharing under universal healthcare—making vaccination free and accessible for everyone.

All vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) and approved by the FDA must be covered without cost-sharing under any universal healthcare system, Medicaid, and Medicare. This coverage must extend beyond the childhood immunization schedule to include adult vaccines for influenza, COVID-19, RSV, pneumococcal disease, shingles, and all other ACIP-recommended indications. Removing cost barriers to vaccination is among the most cost-effective public health investments available: the return on investment for childhood vaccines alone has been estimated in the hundreds of dollars of healthcare cost savings per dollar of vaccine investment. Coverage must include both vaccine product costs and administration costs, and must not impose prior authorization requirements for ACIP-recommended vaccines.

Fund research into vaccine hesitancy and evidence-based communication strategies

Federal funding would support evidence-based research into why people hesitate to vaccinate and what communication approaches effectively and respectfully address those concerns.

Vaccine hesitancy is a complex behavioral phenomenon driven by a mix of factors including distrust of institutions, misinformation exposure, cultural and religious concerns, prior negative healthcare experiences, and the failure of public health communication to meet people where they are. Dismissing vaccine-hesitant individuals as irrational does not reduce hesitancy and may increase it. NIH, CDC, and HRSA must fund research into: the psychological, social, and structural drivers of vaccine hesitancy across different communities; the effectiveness of communication interventions including motivational interviewing, trusted messenger programs, and community-based outreach; the role of social media algorithms in amplifying vaccine misinformation; and the effectiveness of de-bunking versus pre-bunking approaches to misinformation. Findings must be rapidly translated into training programs for healthcare providers and public health communicators. All research must be conducted with community partners, particularly in communities with high vaccine hesitancy, and must treat hesitancy as a solvable public health problem, not a moral failing.

Integrate the WHO definition of health into federal healthcare policy

Federal healthcare policy would adopt a broader definition of health—one that includes mental and social well-being, not just the absence of disease—shaping how coverage and research priorities are set.

The World Health Organization's 1948 definition of health — "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" — establishes a standard of health that the U.S. healthcare system is not designed to achieve. American healthcare is structurally organized around the treatment of disease after it occurs, with minimal investment in the conditions that support genuine well-being. Federal healthcare policy — including research priorities, coverage definitions, quality measurement, and funding allocation — must formally adopt the WHO definition of health as the governing standard. This means that: coverage and care delivery must address social determinants; quality metrics must measure patient-reported well-being, not only mortality and morbidity; and research priorities must include interventions that improve quality of life across all dimensions of the WHO definition.

Fund research into interventions that improve energy, mood, and daily functioning beyond disease treatment

Federal research funding would go toward understanding what actually improves energy, mood, and daily functioning beyond just treating disease—a massive research gap that affects millions of people.

The vast majority of healthcare research measures success by the absence of disease or the absence of death. Relatively little funded research asks: what interventions make people feel genuinely well — energetic, engaged, capable, socially connected, and fulfilled? This is not a trivial question. A large proportion of patients who present to primary care do not have diagnosable diseases but do experience reduced energy, poor sleep, low mood, cognitive fog, or reduced quality of life that significantly impairs daily functioning. NIH must create and fund a dedicated program for wellness and quality-of-life research, including: randomized trials of interventions targeting energy, sleep quality, mood, and functional capacity in non-clinical populations; longitudinal studies of the lifestyle, social, and environmental factors that predict long-term well-being; and the development and validation of patient-reported outcome measures for wellness dimensions beyond disease-specific measures.

Require patient-reported outcome measures in all federally funded healthcare research

All federally funded healthcare research would be required to include patient-reported outcomes—measuring what patients actually experience—not just clinical markers that may not reflect how people actually feel.

Patient-reported outcome measures (PROMs) — standardized instruments that capture patients' own assessments of their symptoms, function, and quality of life — are underutilized in U.S. healthcare research and clinical practice despite strong evidence of their value in improving care quality and patient-provider communication. All federally funded healthcare research must include validated, disease-appropriate PROMs as primary or co-primary endpoints alongside clinical outcome measures. Healthcare quality programs including Medicare and Medicaid must incorporate standardized PROMs into quality reporting requirements. Development and validation of new PROM instruments for understudied populations and conditions must be funded. The goal is to ensure that the healthcare system measures what patients actually experience, not only what clinicians can observe or measure.

Fund research into longevity, healthy aging, and compression of morbidity

Federal investment would support research into healthy aging and extending the years people live in good health, not just extending total lifespan.

The goal of longevity research is not simply to extend lifespan but to extend healthspan — the number of years lived in good health, with full functional capacity and quality of life. Compression of morbidity (the shift of illness and functional decline to the last period of life) represents a profound humanitarian and economic goal: enabling people to live fully until near the end of life, rather than spending years or decades in decline. The NIH National Institute on Aging must receive enhanced funding for: research into the biological mechanisms of aging and age-related decline; clinical trials of interventions that measurably extend healthspan; lifestyle, dietary, and social factors that predict healthy aging; and prevention of age-related cognitive decline. Research must include diverse populations, as aging trajectories differ substantially by sex, race, socioeconomic status, and geographic context.

Fund mental wellness and positive psychology research, not only mental illness treatment

Research into what promotes positive mental health—not just what treats mental illness—would receive dedicated federal funding, addressing a major gap in the current research agenda.

Mental health research is dominated by the study of pathology — the mechanisms, diagnosis, and treatment of mental illness. Far less is known about the determinants of mental wellness: what enables resilience, sustains positive relationships, supports a sense of meaning and purpose, and allows people to thrive under stress. NIMH must create a dedicated program for mental wellness and positive psychology research, with particular focus on: evidence-based interventions that build resilience and psychological flexibility in general populations; the role of social connection, community belonging, and purpose in protecting mental health; environmental and structural factors that support population-level mental wellness; and the effectiveness of workplace, school, and community programs designed to reduce psychological distress before it becomes clinical illness. Research must not be limited to individually focused interventions but must examine collective and structural determinants of mental wellness.

Redesign healthcare quality measurement to capture wellness and quality-of-life outcomes

Healthcare quality measurement would be redesigned to capture wellness and quality-of-life outcomes, not just whether a provider performed the right procedure or avoided complications.

Healthcare quality in the United States is measured primarily through process metrics (did the provider perform the recommended service?) and clinical outcome metrics (did the patient survive? did the lab value normalize?). These metrics capture a small fraction of what patients actually care about. Healthcare systems must be incentivized and required to measure what matters to patients. CMS quality programs — including those affecting hospital reimbursement, physician performance, and insurance plan ratings — must incorporate standardized patient-reported outcome measures, functional status assessments, and quality-of-life metrics as primary quality indicators. Research must fund the development, validation, and implementation of these measures across care settings and populations. Healthcare delivery system reform must make the achievement of patient-defined wellness goals — not merely the absence of clinical pathology — a central organizational objective.