The Regulatory Roadmap: Five Critical Questions for Evaluating Regulatory Risk for Longevity Companies

Companies operating in this space range from biotech innovators targeting the biology of aging, to digital health platforms delivering personalized insights, to consumer brands focused on performance, recovery, and wellness. While the unifying theme is a focus on extending healthspan — the length of high-functioning years lived — and optimizing human performance, the regulatory considerations that apply to any given business can vary dramatically depending on its specific business model.

For founders, operators, and investors, understanding where a company falls along the regulatory spectrum is not simply a compliance exercise. It is a strategic imperative that shapes product design, go-to-market strategy, capitalization, strategic partnerships, and exit opportunities. Against that backdrop, below are five foundational questions every longevity company should evaluate to understand its regulatory obligations and risk profile.

1. Does your longevity company make, distribute, or sell a regulated product?

Many longevity companies begin as technology or consumer brands, only to discover their product roadmap places them squarely within the jurisdiction of the US Food and Drug Administration (FDA). The question these companies face is whether their offering is regulated under the Federal Food, Drug, and Cosmetic Act (FDCA) as a drug, biologic, or medical device, each of which carries its own development, approval, manufacturing, labeling, and post-market surveillance requirements. 

For companies operating in the wearable and digital health space, a particularly active area of regulatory focus is the line between a regulated “medical device” and a lower risk “general wellness” product. The FDA has issued guidance outlining when software or hardware that tracks or influences health metrics may fall outside formal device regulation. However, this boundary is increasingly tested as platforms incorporate more advanced analytics, predictive modeling, and health-related insights, as was recently evident with the FDA’s assertion against Whoop that its Blood Pressure Insights feature is a medical device. 

At the other end of the spectrum, companies offering dietary supplements or nutraceuticals often assume they are “unregulated.” In reality, supplements are governed primarily by the Dietary Supplement Health and Education Act of 1994 and related provisions of the FDCA, which establish a distinct regulatory framework for ingredient safety, current good manufacturing practices, labeling, and the types of structure and function claims that may be made without triggering drug classification. As a recent example, in a January 2026 warning letter, the FDA concluded that although a company marketed its product as a dietary supplement, the product — as used in the company’s clinical study — was a drug because the protocol enrolled people with mild to moderate dementia and aimed to show improvement in cognitive status, signaling an intended use to treat a disease and thereby crossing the agency’s boundary for what constitutes a drug.

2. Does your longevity company provide services requiring a license?

While many longevity businesses focus on product delivery, a growing segment of the market is service-driven, offering clinical care, testing, coaching, or personalized interventions. When a company’s activities cross into the provision of medical or other licensed services, additional layers of regulation come into play.

If a company is engaged in the practice of medicine or another profession requiring a license, such as nursing, dietetics, or psychology, it must account for state-by-state licensing requirements. In many jurisdictions, the business also must navigate corporate practice of medicine laws that restrict the extent to which non-licensed individuals or entities may own, control, or influence a medical practice.

These rules shape how longevity clinics, concierge medicine practices, and telehealth platforms structure their corporate entities, management arrangements, and revenue models. A misaligned structure can create regulatory exposure that affects investment and expansion opportunities as well as day-to-day operations.

Testing services present additional considerations. Companies offering biomarker analysis, genomics or epigenetics testing, microbiome testing, or other services involving human biospecimens must evaluate whether their operations trigger federal Clinical Laboratory Improvement Amendments certification and state laboratory licensure requirements. Similarly, businesses offering full-body magnetic resonance imaging scans and other imaging services must consider whether their facility must be licensed or whether their usage of imaging equipment triggers state certificate-of-need laws. 

3. What data does your longevity company collect?

Data is the lifeblood of the longevity ecosystem. From continuous physiologic monitoring via wearables to longitudinal health profiles and genomic datasets, many companies in this space collect information that is deeply personal.

A common misconception is that all “health data” is governed by the federal Health Insurance Portability and Accountability Act (HIPAA). In fact, HIPAA applies only to “covered entities,” such as health care providers engaged in certain electronic transactions and health plans, and their “business associates.” Many digital health platforms and other longevity companies fall outside that framework.

That does not mean they operate in a regulatory vacuum. A growing patchwork of state comprehensive privacy laws now imposes heightened obligations around the collection, use, sharing, and protection of consumers’ “sensitive personal data,” which may include mental or physical health or treatment information, “neural data,” and genetic data, while others specifically regulate “consumer health data.” These laws often require affirmative consent, disclosures regarding a company’s privacy practices, and robust security safeguards, particularly when data is used for targeted marketing, training AI systems, or other purposes that may be attenuated from delivery of the core product or service offering. Additionally, certain state privacy laws require companies to complete a risk assessment when processing presents a “significant risk” to consumers’ privacy; processing “sensitive personal data” is expressly treated as such a significant risk activity and therefore triggers the assessment requirement. In some states, a full or summary version of the risk assessment must be provided to the state’s attorney general or other privacy regulator, making it advisable to complete the assessment under attorney-client privilege. 

Layered on top of these regimes is the Federal Trade Commission (FTC) Health Breach Notification Rule, which may apply to companies falling outside HIPAA’s scope that offer health apps or connected devices. This rule requires notice to consumers, the FTC, and in some cases the media following certain breaches of security involving identifiable health information. Notably, the rule was modified in 2024 to clarify that a reportable breach is not limited to traditional data security intrusions and includes a broader range of unauthorized acquisitions, uses, or disclosures of unsecured personally identifiable health information, including certain data-sharing, tracking, and third-party disclosure practices.

4. Does your longevity company make health-related claims about your products or services?

The longevity market is fueled by bold ideas and ambitious aims to challenge status quo positions about the human aging process. However, claims about anti-aging effects, disease prevention, performance enhancement, or scientific validation can quickly draw regulatory scrutiny.

Under the FTC Act and parallel state consumer protection laws, companies must ensure their advertising and marketing claims are truthful, not misleading, and substantiated by competent and reliable scientific evidence. This applies not only to formal advertising, but also to websites, social media, influencer arrangements, testimonials, and investor materials that are repurposed for consumer audiences.

Enforcement in this area has been particularly active around anti-aging representations, regenerative medicine, and stem cell-related claims. For example, recent FTC actions have challenged clinics and marketers for promoting stem cell therapies as treatments for conditions such as arthritis, chronic pain, and neurodegenerative disease without adequate scientific substantiation, and for misrepresenting their products as FDA-approved or clinically proven when no such approval or evidence existed.

5. How is your longevity company paid for its products or services?

A longevity company’s monetization model may present significant regulatory implications. Companies that collect payment directly from consumers must account for a growing body of federal and state consumer protection laws governing subscription services, automatic renewals, and other aspects of the consumer billing and payment cycle. These rules typically require clear and conspicuous disclosures of material terms, affirmative consumer consent to ongoing charges, and straightforward mechanisms for cancellation. In the digital health context, where services are often delivered through apps and online platforms, regulators have increasingly scrutinized how payment terms are presented in user interfaces and whether consumers can reasonably understand and control their financial commitments.

Longevity companies operating in business-to-business or enterprise models may face a different set of considerations. As more longevity-focused products and services are integrated into employer wellness programs, health system partnerships, and payer-sponsored initiatives, companies must evaluate how value-based care arrangements, outcomes-based compensation methodologies, and emerging federal programs — such as the Centers for Medicare & Medicaid Services’ ACCESS pilot in the Medicare program — may shape both revenue streams and compliance exposure. These arrangements often implicate not only contract and reimbursement issues, but also data sharing, reporting, and performance measurement requirements.

In some cases, longevity businesses may intersect directly with third-party payers, including private insurers, employer-sponsored health plans, and government programs. This may raise questions about whether a product or service constitutes a reimbursable health care product or service subject to insurance billing rules. For example, companies offering diagnostic testing, clinical services, or care coordination may need to assess how coverage determinations, network participation, and utilization management requirements affect their operating model and growth strategy.

Concierge and cash-pay longevity practices must also be mindful of the Medicare mandatory claims submission rule, which generally requires participating and non-participating providers to submit claims to Medicare for covered services furnished to Medicare beneficiaries, even when the practice’s business model is oriented around direct patient payment. Failure to account for this requirement can create regulatory risk that extends beyond billing practices to how services are marketed to patients and reflected in patient agreements and membership terms, underscoring how closely payment structure and compliance are intertwined.

Bringing It All Together

What makes the longevity ecosystem so dynamic is also what makes it complex: few companies fit neatly into a single regulatory box. A wearable platform may also offer a testing service. A supplement brand may build a coaching app. A physician may sell supplements at her longevity clinic and endorse those supplements in influencer content on social media.

A certain degree of regulatory friction is inevitable in this dynamic environment. Rather than eliminate this regulatory friction entirely, the goal should be to anticipate it, design around it, and use compliance strategy and risk management as a competitive advantage. As the longevity space continues to mature, thoughtful regulatory planning can accelerate commercialization, strengthen investor and consumer confidence, and create a more resilient foundation for growth.