“A wave of new ventures is no doubt poised to deliver fresh possibilities in DTC [direct-to-consumer] health care. However, Big Tech is uniquely positioned to scale their own DTC health care services rapidly and efficiently or can choose to provide the technological backbone for traditional HCOs [health care organizations] or new entrant startups. Big Tech platforms have hundreds of millions of users and access to hyperpersonalized data from search, social media interactions, mobility data, and LLM [large language model] engagement. Google Search has long been a de facto patient decision support tool for diagnosis and more, well before being tuned for health care. Emerging chatbots are certainly widely used by patients for medical insights, whether as initial guidance or a second opinion. OpenAI, Microsoft, and other LLM vendors will aggressively develop these DTC capabilities. Although today the medical accuracy and consistency of LLM output are not validated, the ease of access by patients to personalized information and recommendations is unprecedented.
Unlike most HCOs, which have ceded control of their data assets to EHR vendors, Big Tech maintains control over their own data ecosystems, allowing them to iterate quickly and optimize their offerings. [..] DTC health care is potentially less constrained by regulation. Without substantial investment in infrastructure and innovation, traditional HCOs risk sacrificing market share to better-equipped DTC innovators.
Forces Shaping the Shift
Declining Access to Primary Care
Primary care is diminishing. In the 2024 residency match, more than 1200 positions in family medicine, nearly 1000 in internal medicine, and more than 500 in pediatrics went unfilled. Many legacy HCOs have yet to recognize the urgency of adapting their workforce, including upskilling advanced practice clinicians with AI. In contrast, DTC entrants will start with an optimized workforce mix or fully automate key traditional HCO functions.
The Shift Toward Consumer-Controlled Health Data
[..] Exercising rights to their own data across platforms, patients can now combine their EHR [electronic health record] data with digital biomarkers from wearables, genomic information, social media, food purchases, location information, and environmental exposure. AI-driven tools could use these multidimensional profiles for highly personalized insights, diagnoses, identifying therapies, or predicting risks.
Potential Pitfalls
Alignment of Incentives
Many DTC platforms originate in technology or retail, bringing a market-driven mindset that shapes their approach to patient care. With a focus on speed, scalability, and targeted services, they can be nimble and adapt quickly in tech-enabled care. They can also go astray. Cerebral, a telehealth company focused on mental health, faced federal investigation and reached a settlement over allegations that it incentivized clinicians to overprescribe medications such as Adderall, prioritizing volume and profitability over patient safety.
Meanwhile, the DTC market is emerging alongside a broader trend of increasing corporatization of traditional health care. Nearly 80% of physicians are now employed by hospitals, health systems, or corporate entities, and for-profit enterprises and private equity firms are acquiring a growing share of HCOs. This consolidation raises concerns that financial returns may overshadow emphasis on patient-centered outcomes, particularly if the focus on highmargin services leaves more complex or underserved populations behind. Patients will find themselves navigating an increasingly commercialized health system, whether seeking care through conventional HCOs, DTC offerings, or hybrid models. In a consumerdriven market, transparent performance metrics and real-time patient feedback could intensify competition in terms of quality, spurring innovation and improvements in care.
Sustainability
Currently, DTC health care companies operate in a landscape where failure is an option, particularly as the sector navigates a digital health winter, with investments dropping from $29.2 billion in 2021 to $8.3 billion in 2024. Sustainable business models may be elusive.
Privacy and Security Risks
The US Department of Health and Human Services Office for Civil Rights enforces Health Insurance Portability and Accountability Act regulations, but once health data move from an HCO into a consumer-controlled app (eg, across a FHIR API), regulatory oversight shifts to the Federal Trade Commission (FTC). This transition leaves health data subject to different and often less stringent protections. The FTC’s updated Health Breach Notification Rule requires vendors of personal health records and related services to notify consumers of breaches. However, this protection does not regulate broader issues like the sale of data, leaving users vulnerable to unexpected changes in how their health data are handled, including potential sale to or sharing with third parties, issues highlighted by 23andMe, a prominent DTC genetic testing company. With terms of service that can change at a company’s discretion, consumers face tough challenges in understanding and controlling how their health data are used.
Limited Oversight
Some AI tools delivering care directly to consumers may fall under US Food and Drug Administration regulation as software as a medical device. AI systems guiding health care professionals within DTC companies may or may not be scrutinized or regulated, depending on their intended use and the degree to which they influence clinical decision-making. Although the Health Data, Technology, and Interoperability: Certification Program Updates for 2023 (HTI-1) Final Rule includes transparency requirements for decision support interventions used in certified health information technology, many DTC tools will operate outside its purview.
Digital Divide
For patients seeking care in lower-resourced settings, such as Federally Qualified Health Centers, complementary AI-driven DTC models could democratize access, such as supporting individuals with low health or English literacy. However, DTC solutions also risk exacerbating disparities for those lacking digital literacy, broadband access, or the necessary technology to participate fully. Additionally, older adults may have difficulty using the required technologies. Without forethought, DTC solutions could deepen inequities in access and outcomes.
The Path Ahead
Patients will increasingly expect from health care what they are enjoying in other industries—convenient, technology-driven solutions exploiting AI that service their needs and save them time. Reduced access to primary care and advancements in AI create momentum for change. This transformation is not guaranteed to occur within traditional HCOs. DTC models, leveraging AI, are well positioned to offer scalable solutions that bypass traditional channels and address growing demand.
DTC care may use assistive tools that integrate with existing care frameworks and disruptive services that operate independently of traditional HCOs. Synergies between traditional HCOs and DTC companies, or HCO-driven DTC efforts, could integrate assistive tools, improving care without fully displacing existing structures.
However, some DTC companies already offer a hybrid model that combines virtual and physical interactions, and both HCOs and DTC companies may compete on virtual AI-assisted care.”
Full interview, KD Mandl, Journal of American Medical Association, 2025.2.24