Digital Health Blog

Digital health company UpDoc announced that it received Food and Drug Administration approval for what the company describes as the first Software as a Medical Device (“SaMD”) incorporating patient-facing large language models for medication management purposes. The UpDoc platform, designed on previously approved tools to assist in management of type 2 diabetes medication, integrates with electronic health records and existing clinical workflows and allows patients to submit information to produce treatment plans generated in accordance with clinician-defined protocols.

While this clearance indicates the FDA’s willingness to authorize certain AI-enabled clinical tools, it does not establish a required approval pathway for all LLM-based healthcare products. Federal and state regulators continue to pursue multiple oversight approaches to regulating AI in health care, including an increasing number of states expressing interest in facilitating patient access to AI-enabled care through regulatory sandbox programs. Entities developing clinical and patient-facing AI technologies should consider governance and legal strategies calibrated to the specific intended use of the product at issue, as well as the implementation of protocols sufficient to demonstrate the safety, effectiveness, and reliability of the underlying AI technology.

The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), announced new oversight measures for the Trusted Exchange Framework and Common Agreement (TEFCA), the national interoperability network designed to facilitate secure electronic exchange of health information. ONC has awarded a contract to enhance audit, review, and compliance functions and is conducting additional reviews of Qualified Health Information Networks (QHINs) and participating organizations to ensure adherence to TEFCA requirements. HHS also reported that TEFCA has grown from approximately 10 million exchanged health records to more than 1 billion records in less than one year.

The Centers for Medicare & Medicaid Services (CMS) has announced the establishment of a new organizational component, the Office of Health Technology and Products (OHTP), effective June 9, 2026. OHTP is intended to provide enterprise-wide leadership and oversight of CMS’s health care technology modernization efforts, as well as the development and management of digital products supporting Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and other CMS-administered programs. The office will operate in coordination with the CMS Chief Information Officer (CIO).

OHTP will include several functional components, including the Open Source Program Group, the Standards & Interoperability Group, the Product Development Group, and Digital Services at CMS. This organizational change aligns with the Administration’s broader efforts to accelerate the digital transformation of CMS and modernize the agency’s technology infrastructure.

The Trump administration has issued a new executive order on artificial intelligence that emphasizes cybersecurity safeguards while pulling back from more stringent federal oversight proposed earlier. The directive introduces a voluntary review process requiring companies to submit advanced AI models to the government 30 days before public release—shortened from an earlier 90-day proposal—alongside new efforts to coordinate with industry on identifying and addressing security vulnerabilities.

Framed as a balance between innovation and risk mitigation, the order is narrower than expected and avoids mandatory licensing or preclearance requirements, reflecting industry concerns about overregulation. At the same time, it signals growing urgency within the administration to address national security risks posed by increasingly powerful AI systems, including steps to strengthen federal network defenses and expand collaboration with critical infrastructure partners.

Reps. Jay Obernolte (R-CA) and Lori Trahan (D-MA) have unveiled a bipartisan discussion draft of the Great American AI Act, a proposal designed to establish a clear federal framework for governing artificial intelligence in the United States. Released to solicit public and stakeholder feedback ahead of formal introduction, the draft aims to balance rapid innovation with safeguards by promoting U.S. leadership in AI, setting consistent national standards to avoid a fragmented state-by-state approach, and introducing stronger accountability and protections for workers, consumers, and national security as the technology continues to evolve. While this is the first comprehensive bipartisan legislative marker put out this Congress, the draft has already received pushback from members of both parties. House Democrats have mainly been concerned of the inclusion of language to preempt state laws for at least three years. The Democratic House Commission on AI has indicated it does not support the draft in its current form. House Republicans are concerned changes could inhibit innovation in the space.

Still, the bipartisan nature of the draft does indicate areas of some agreement that could be worked out further through the Committee process or other iterations of the bill.

The Joint Commission launched its Responsible Use of AI in Healthcare (RUAIH) certification program, a voluntary certification recognizes hospitals and health systems that have established the governance structures, safeguards, monitoring processes, and workforce education needed to deploy AI responsibly. The certification standards are organized around five major areas: (1) governance; (2) effective data management; (3) risk and bias reduction; (4) monitoring, evaluating, and validating safety, performance, and responsible use; and (5) transparency, education, and training. The certification program does not evaluate or certify individual AI products or appropriate use cases. Rather, it assesses whether organizations have implemented sound governance and responsible-use practices.

Paralleling this announcement, the Coalition for Health AI (CHAI) released a complementary series of in-depth governance playbooks address core governance elements such as organizational AI policy and oversight committees, risk and impact assessments, lifecycle management, responsible data use, and third-party vendor oversight. The playbooks operationalize the joint guidance the organizations issued by CHAI and the Joint Commission in September 2025 and are intended to provide a practical framework for organizations pursuing the Joint Commission’s RUAIH certification.

The Coalition for Health AI (CHAI) also announced a new Best Practice Guide aimed at helping states, developers, and health organizations responsibly deploy artificial intelligence in Medicaid eligibility processes. Developed with input from more than 40 health care organizations, the guidance provides practical, role-based recommendations for high-stakes functions like enrollment and eligibility adjudication, while emphasizing transparency, fairness, and human oversight.

Designed as a timely resource ahead of federal implementation deadlines, the guide seeks to help modernize Medicaid operations, reduce administrative burden, and minimize the risk of inappropriate coverage loss—ensuring AI supports efficient processes without compromising patient access or equity.

On May 14th, the Supreme Court issued a one-paragraph order allowing mifepristone to continue to be prescribed via telehealth and dispensed by mail, blocking a Fifth Circuit decision that would have reimposed an in-person dispensing requirement formally lifted by the FDA in 2023.

The order came in response to emergency requests from Danco Laboratories LLC and GenBioPro Inc., both manufacturers of the brand-name and generic versions of mifepristone, who sought Supreme Court intervention after the Fifth Circuit ruled against remote prescribing at the beginning of May. Louisiana v. Food and Drug Administration, No. 26-30203 (5th Cir. May 1, 2026). Justice Alito had initially issued a week-long administrative stay of the Fifth Circuit decision while the Court considered the manufacturers’ full applications. The May 14th order keeps mifepristone fully available while the underlying litigation proceeds.

The ruling’s stakes are substantial. Medication abortion now accounts for the majority of pregnancy terminations in the United States, and mifepristone has been available via telehealth since 2021; first through the FDA’s decision to stop enforcing the in-person dispensing requirement during the COVID-19 pandemic, then formally through a 2023 rule change. The current reprieve may prove temporary, however: the FDA is conducting an ongoing safety review of mifepristone, the outcome of which could provide the basis for reimposing pre-2021 in-person requirements.

Pennsylvania has filed suit against Character Technologies, Inc., the operator of Character.AI, alleging the unlawful practice of medicine in violation of Pennsylvania’s Medical Practice Act. The action is the first of its kind brought by state regulators against a developer of chatbot for the unlicensed practice of medicine.

The complaint alleges that Character.AI permitted chatbot “characters” to hold themselves out as licensed physicians in conversations involving diagnosis, assessment, and treatment with users in Pennsylvania. Responding to input from state investigators the chatbot affirmatively represented that it was a licensed psychiatrist in both the United Kingdom and Pennsylvania, even providing a fictitious Pennsylvania license number.

This complaint comes against a backdrop of expanding civil litigation exposure for developers targeting not only Character.AI, but OpenAI’s ChatGPT and Google’s Gemini. The plaintiffs in these cases assert theories of defective design, failure to warn, and negligent deployment of emotionally interactive AI systems that contributed to user self‑harm and suicide, and which had significant impact on minors and other vulnerable users.

Together, these developments underscore the accelerating regulatory and litigation risk for AI platforms as they toe the line between general information tools and regulated professional services, particularly in health care and behavioral health contexts. Companies deploying generative AI in consumer‑facing environments should carefully reassess marketing claims, output controls, and professional disclaimers, and should anticipate increased from state regulators.

The Department of Health and Human Services (HHS) along with the American Society of Nephrology (ASN) announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million competition to accelerate innovation supporting living organ donation through digital health and other tools. In addition, ONC also announced it would work with the nephrology community on data standardization and health information technology (HIT) improvements across the kidney care ecosystem to support these efforts.