On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides recommendations on the use of AI intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality. The guidance discusses the use of AI models in the nonclinical, clinical, post-marketing, and manufacturing phases of the drug product life cycle. This is the first time FDA has proposed draft guidance on the use of AI for the development of drug and biological products and may provide insight on how AI models in medical product regulation should be assessed. The FDA is seeking public comment on the proposed guidance by April 7, 2025. Continue Reading FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making
Artificial Intelligence
Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care
On November 8, 2023, the Senate Health, Education, Labor and Pensions (HELP) Committee Subcommittee on Primary Health and Retirement Security discussed the impact of artificial intelligence (AI) on the healthcare sector in the Committee’s second AI hearing in nine days. The hearing comes as the White House and Congressional leaders seek to quickly respond to AI threats, mitigate its dangers, and harness its potential for American industry. Senators discussed the recent Executive Order issued by the White House to guide AI regulation and innovation across all sectors, including in the health and human services sectors.Continue Reading Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care
FDA Publishes Principles for AI and ML in Medical Devices
On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices. The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.
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Podcast: Digital Health Innovation
Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records sit down with Jodi Daniel and Ambassador Robert Holleyman to discuss how regulators—across the U.S. and the…
Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule
CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market.
Virtual Check-Ins
CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”
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FDA Issues New Guidance for Clinical and Patient Decision Support Software
This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers. It also provides guidance on FDA’s interpretation of new software provisions in Section 3060 of the 21st Century Cures Act.
Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days.
Continue Reading FDA Issues New Guidance for Clinical and Patient Decision Support Software