Recently, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., has articulated a new Administration goal of having every American use a wearable health device within the next four years. Secretary Kennedy’s announcement sparked important conversations and brought needed attention to the underutilization of wearables for prevention and treatment across the American healthcare system.

Wearable technologies have already demonstrated their ability to enhance access to care and to empower patients to take an active role in their health management. By continuously monitoring metrics such as sleep quality, heart rate, and stress levels, these devices facilitate enhanced engagement by patients in their own health. The real-time patient-generated health data (PGHD) collected can inform personalized treatment protocols, guide training plans, and trigger timely interventions, such as stress alerts. This data-driven approach enhances situational awareness for both patients and providers, enabling more informed decisions regarding prevention and treatment. And these different kinds of PGHD are vital to developing and leveraging artificial intelligence (AI) capabilities in health.

The Connected Health Initiative (CHI) is committed to enabling greater use of wearable technology for both prevention and care. For individuals in rural or underserved areas, where regular healthcare engagement is often limited to sporadic physician visits, wearables can bridge the gap between appointments, reducing care fragmentation and support more cohesive, patient-centered care. Secretary Kennedy’s announcement brought waves of encouragement and excitement from the connected health community.

To assist the Administration in achieving its goal, CHI pulled together a range of short-term proposed actions this Administration can take, without additional congressional approvals, from the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Defense Health Agency (DHA). Additionally, CHI recently organized a sign-on letter to Secretary Kennedy providing key principles for healthcare AI governance.

 Centers for Medicare & Medicaid (CMS):

In our letter to CMS, CHI urged for the rapid modernization of Medicare through the integration of wearable devices in order to improve patient outcomes, enhance population health management, reduce costs, and support the healthcare workforce. CHI’s recommendations to CMS:

  • First, the Center for Medicare and Medicaid Innovation should launch a new pilot to explore the impacts of wearables and the timely leveraging of PGHD, focusing on individuals patient outcomes, population health management, and cost savings
  • Second, CMS should pursue pragmatic updates across its existing payment rules to support the responsible adoption of PGHD and wearables.

For more detail on how each of these recommendations, read the full letter: https://connectedhi.com/chi-letter-regarding-the-center-for-medicare-and-medicaid-services-action-needed-to-provide-every-american-with-access-to-wearables-within-four-years/

 Food and Drug Administration (FDA):

In our letter to the FDA, CHI proposed the creation of a Commissioner’s National Priority Voucher (CNPV) program for medical devices, modeled after the FDA’s existing drug CNPV programs. This initiative would drive innovation aimed at expanding prevention and treatment options to address unmet public health needs, including the chronic disease crisis. While the current CNPV program is limited to drugs, expanding or replicating it for medical devices would represent a critical investment in advancing care. Wearables’ ability to predict risks, personalize treatment, and optimize resource allocation at scale offers the potential to transform healthcare through continuous monitoring and advanced data analytics. The FDA has the authority to implement a device CNPV program, and doing so would align with its mission to protect public health, foster innovation, and address emerging healthcare challenges.

For more detail, read the full letter: https://connectedhi.com/chi-request-for-the-creation-of-a-food-and-drug-administration-medical-device-commissioners-priority-review-voucher-program/

Defense Health Agency (DHA):

In our letter to DHA, CHI urged the rapid modernization of TRICARE, the uniformed services healthcare program for active-duty members and their families. Currently, TRICARE excludes coverage for wearable devices unless they meet an inflexible list of criteria. The criteria for coverage require the exclusion of all mobile medical applications (MMAs) and that do not meet the definition of durable medical equipment (DME). Additionally, TRICARE does not reimburse care teams for time spent reviewing or integrating wearable data into clinical care, limiting the use of connected health solutions common elsewhere in the healthcare system. CHI’s recommendations to DHA:

  • First, CHI urges DHA to launch a new pilot at sufficient scale to explore the impacts of wearables and the timely leveraging of PGHD, focusing on force readiness, individual patient outcomes, population health management, cost savings, and how the provider workforce is affected.
  • Second, CHI asks DHA to initiate a new rulemaking to identify opportunities for how TRICARE beneficiary coverage policies for digital health innovations can be modernized and implement responsive changes as soon as practicable.

For more detail on these recommendations, read the full letter: https://connectedhi.com/chi-letter-to-acting-director-david-j-smith-at-the-defense-health-agency-regarding-tricare-modernization/

 Healthcare and Artificial Intelligence Sign-On Letter:

A CHI-organized sign-on letter, endorsed by more than 40 cosigning organizations, outlined key principles to guide future policy alignment. These principles, all well within HHS’s existing authority, aim to foster forward-looking policies that advance the American healthcare system through the safe and responsible adoption of AI. Below are several highlighted policy initiatives:

  • Quality Assurance and Oversight: Across HHS, adopt a risk-based approach to healthcare AI that tailors risk mitigation to the potential harms of intended and expected uses. HHS should clarify liability considerations for clinicians using AI and providers offering digital health tools, with the goal of encouraging innovation and adoption.
  • Transparency and Explainability: Provide clear, risk-based communications that inform downstream healthcare stakeholders about relevant data requirements, intended uses, limitations, target populations, bias mitigation, and applications of AI tools. These communications should disclose sufficient detail to help providers assess when a tool is appropriate for individual patients, clarify whether the tool augments or automates clinical workflows, and specify compliance with all applicable legal and regulatory requirements.
  • Interoperability: Ease data access and improve interoperability, while protecting data security, to foster cooperation, trust, and openness among patients, providers, health AI technology developers, and researchers. A truly interoperable healthcare system is one that enables and engages patients across multiple privacy-preserving platforms using open APIs, enabling the secure integration of patient-generated health data into electronic health records.

For more details on these recommendations, read  the full letter, including the complete list of principles and signees: https://connectedhi.com/chi-healthcare-and-artificial-intelligence-sign-on-letter-to-u-s-secretary-of-health-and-human-services-robert-f-kennedy-jr/

Each of the above are actionable steps that the Administration can take now to  integrate innovative wearable technologies (and AI solutions powered by the PGHD they collect) into  the American healthcare system. These actions are important, but initial, steps that must be taken to realize the Administration’s new wearables goal.