On December 17, 2024, the House Task Force on Artificial Intelligence (Task Force) released a highly-anticipated report titled, “Bipartisan House Task Force Report on Artificial Intelligence,” (the Report) which establishes guiding principles and issues recommendations to guide U.S. innovation in artificial intelligence (AI), including in the healthcare sector. The Report is intended to serve as a blueprint for Members of Congress as they conduct oversight and introduce legislation to address advances in AI technologies, including the regulation of health-specific AI applications.Continue Reading House Task Force on AI Issues Report and Proposes Healthcare Recommendations
Taking a Closer Look at ONC’s AI Transparency Regulations
In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies, for numerous use cases in clinical and health care settings, including to aid in clinical decision-making. Currently, healthcare AI systems and tools have both clinical and administrative applications, namely monitoring patients, recommending treatments, predicting health trajectories, recording clinical notes, optimizing operational processes, and supporting population health management.
The Department of Health and Human Services (HHS) and federal agencies have been developing policies to advance transparency and manage risks for the development and use of AI/ML-powered health care technologies. Most recently, the Office of the National Coordinator for Health Information Technology (ONC) issued regulations that addresses predictive models and health AI systems.Continue Reading Taking a Closer Look at ONC’s AI Transparency Regulations
FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).Continue Reading FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
FDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring devices used for patient monitoring at the conclusion of the COVID-19 public health emergency (PHE). Specifically, the FDA will continue to allow most remote monitoring devices to be used in home settings and to allow certain hardware or software changes to allow for increased remote monitoring capabilities under enforcement discretion.Continue Reading FDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies
On October 11, the National Institutes of Health (“NIH”) issued a request for information (“RFI”), which proposes sample language regarding the use of digital health technologies in research for inclusion in informed consent documents and requests public feedback on the utility and usability of the proposed language. Comments on the RFI are due by December 12, 2023.Continue Reading NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies
Senate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security Policies
Last week, Ranking Member Bill Cassidy (R-LA) of the Senate Committee on Health, Education, Labor and Pensions (“HELP”) issued two separate requests for information (“RFIs”) asking for stakeholder feedback on artificial intelligence (“AI”) and health data privacy policy issues to identify current challenges and receive recommendations to inform potential legislation. With deadlines set for the end of September, each RFI provides a short window for organizations to submit comments.Continue Reading Senate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security Policies
Clinicians Request Continued Medicare Coverage of Remote Patient Monitoring Services at Contractor Advisory Committee Meeting
On February 28, Medicare Administrative Contractors (MACs) contractors—Novitas Solutions (Jurisdictions H and L), First Coast Service Options (Jurisdiction N), Noridian Healthcare Solutions (Jurisdictions E and F), CGS Administrators (Jurisdiction 15), Palmetto GBA (Jurisdictions J and M), and WPS Government Health Administrators (Jurisdictions 5 and 8)—held a multi-jurisdictional Contractor Advisory Committee (CAC) meeting to obtain feedback