WHOOP, Inc.

WHOOP, Inc. respectfully submits the attached comments in response to the FDA Digital Health Center of Excellence’s discussion paper, Generative Artificial Intelligence-Enabled Medical Devices. Please see the attached PDF for WHOOP’s full comments and recommendations.

One Kenmore Square | Suite 601 | Boston, MA 02215 | whoop.com

October 19, 2026

Submitted electronically via Regulations.gov

Re: Docket No. FDA-2026-N-7874 - Considerations for the Regulation of Generative
AI-Enabled Medical Devices

Dear Sir or Madam:

WHOOP appreciates the opportunity to comment on the Food and Drug Administration (“FDA”)
Digital Health Center of Excellence discussion paper, Considerations for the Regulation of
Generative AI-Enabled Medical Devices.

WHOOP develops wearable and digital health technology that helps members better understand
their bodies through continuous physiological monitoring, personalized insights, and guidance
across Sleep, Recovery, Strain, fitness, and health. WHOOP offers general wellness functionality
alongside regulated medical-device functionality, giving WHOOP a direct perspective on how
those functions can coexist within a single consumer health experience.

Generative AI (“GenAI”) has the potential to make personalized health information more
accessible, understandable, and actionable, helping people take greater control of their health
and wellness. Realizing that opportunity requires a regulatory framework that protects
responsible innovation.

WHOOP supports FDA’s effort to build a risk-based framework for GenAI-enabled medical
devices. Our comments focus on a threshold issue that we believe is critical to the future of
consumer health technology: the use of GenAI should not, by itself, convert an otherwise
non-device general wellness function into a medical device.

Technology that helps people better understand their own physiology, recognize patterns, and
engage more actively with their health can support health literacy and put individuals in a better
position to make informed decisions about their wellbeing. FDA should preserve and encourage
that opportunity.

I. Preserve the general wellness space as GenAI evolves
FDA’s existing general wellness framework provides an important foundation for consumer health
technology. As GenAI becomes a more natural and capable way for people to engage with health
information, those principles should remain technology-neutral.

GenAI can meaningfully expand how people understand and use their own health information. A
chart can show that an individual’s Sleep, Recovery, or another metric has changed. GenAI can
 One Kenmore Square | Suite 601 | Boston, MA 02215 | whoop.com

help explain the pattern, compare it with the individual’s baseline, connect it to recent behaviors,
answer follow-up questions, and translate complex information into clear guidance.

That is the opportunity for GenAI in wellness: not simply more data, but more context, more
relevance, and greater ability for individuals to understand and act on information about their own
bodies.

There is also a broader health opportunity. For many people, health information remains difficult
to interpret or disconnected from the decisions they make every day. GenAI can help make
individualized health understanding more accessible at scale by translating complex information
into context people can use. A regulatory framework that preserves room for responsible
GenAI-enabled wellness features can support greater health literacy, engagement, and individual
agency without requiring every personalized health interaction to become regulated as a medical
device.

That added usefulness should not change the nature of the underlying function. Personalization
should not equal diagnosis, and conversation should not equal practicing medicine. A
wellness function should not become a medical device simply because GenAI allows it to
communicate naturally, use a member’s own data, remember relevant context, or respond to
follow-up questions.

To be useful, wellness technology must be able to do more than repeat measurements. Within
the general wellness space, GenAI should be able to:

●​ explain changes and patterns
●​ compare information with a personal baseline
●​ identify general lifestyle or behavioral factors that may be relevant
●​ suggest low-risk activities
●​ answer follow-up questions about wellness information
●​ help an individual decide whether to seek more information or professional input

For example, a wellness function might explain that a member’s sleep duration has been below
their recent baseline, note that bedtime has also shifted later, and suggest returning to a more
consistent sleep schedule. It might observe that a trend has persisted and suggest discussing it
with a healthcare professional if the member is concerned. These functions are materially
different from diagnosing a disease or directing a course of clinical treatment.

FDA should recognize that encouraging appropriate professional follow-up can be an important
safeguard. A wellness tool should not face greater regulatory risk simply because it helps an
individual recognize when professional input may be useful. Appropriate encouragement to seek
 One Kenmore Square | Suite 601 | Boston, MA 02215 | whoop.com

professional input should not, standing alone, convert an otherwise wellness function into a
medical-device function.

WHOOP therefore recommends that FDA:

1.​ Confirm that use of GenAI does not, solely because of the technology used, change
the regulatory status of an otherwise permissible general wellness or non-device
function
2.​ Clarify that conversational interaction, personalization, multi-turn dialogue, or use of
an individual’s own health and wellness data do not independently establish device
status
3.​ Provide concrete examples showing how personalized GenAI-enabled functions can
remain within the general wellness space, including functions that improve health
literacy, contextualize longitudinal information, provide low-risk guidance, and
appropriately encourage professional follow-up.
4.​ Clarify that “action-directing” functionality should be evaluated in context, including
the nature and consequence of the action and the intended use of the function, rather
than simply whether the output recommends that an individual do something.

FDA’s framework should enable people to receive more useful information and context — not
less.

II. Recognize the value of personalization and longitudinal
data in consumer-facing tools
Putting useful health information directly into the hands of the person whose health it concerns is
a benefit of digital health. It should not, standing alone, make a function higher risk.

Personalization is particularly important. WHOOP is built around a simple idea: every body is
different, and each person’s baseline matters. A single measurement is a snapshot. Longitudinal
physiological data can show patterns over days, weeks, months, and years. GenAI can help turn
that history into context an individual can understand and use.

That context can also improve performance and, in appropriate circumstances, reduce risk.
Reliable physiological history and prior interactions may help a system distinguish a one-time
change from a persistent pattern, avoid overreacting to normal individual variation, recognize
conflicting information, or tailor its communication more appropriately. It may also help an
individual identify to their healthcare providers meaningful deviations that might otherwise be
 One Kenmore Square | Suite 601 | Boston, MA 02215 | whoop.com

overlooked during a typical medical visit. Depending on the function, laboratory information,
health records, and other reliable data may provide additional context.

The richness or type of data available to a system should not determine regulatory classification
by itself. The regulatory question should remain what the function is intended to do and consider
the importance of the individual’s autonomy to understand and appropriately use their own
information.

A framework that effectively requires GenAI to remain generic in order to remain low risk would
remove much of the technology’s value. The goal should instead be to preserve the benefits of
personalization by empowering individuals with access to information while addressing
identifiable risks through safeguards proportionate to the particular function.

Oversight should increase when a function moves into diagnosis, treatment, or consequential
autonomous action — not simply because the information is personalized, informed by
longitudinal data, or delivered directly to the individual.

Conclusion
GenAI can make wellness information more understandable, personalized, and useful. FDA can
protect that opportunity by preserving the existing general wellness space.

The core principle is straightforward: regulation should protect consumers while enabling
innovation, ensuring that emerging technologies like GenAI can make personalized health
insights more accessible, actionable, and impactful without unnecessary barriers.

That approach can protect people while preserving the ability of technology to help individuals
better understand their own bodies, take greater agency over their health, and make
better-informed choices. At scale, those individual benefits can support a broader goal shared
across the healthcare system: a population that is more informed, more engaged, and better
equipped to participate in its own health and wellness.

WHOOP appreciates FDA’s early engagement on these issues and welcomes the opportunity to
continue working with the Agency as it develops its approach.

Respectfully submitted,

WHOOP, Inc.