On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.
Healthcare Policy in 2024: What’s Next?
As we head into a new calendar year, in the healthcare space it is worth reflecting on the events of the last few years, as a means of predicting what is likely to come. Last year, the focus in healthcare policy was very much on what will come after COVID; this year, we finally have
Groundbreaking U.S. Artificial Intelligence (AI) Rule May Mean A Healthier New Year In 2025 and Beyond
Exactly 12 days before Christmas, the U.S. Department of Health and Human Services’ Office of the National Coordinator (ONC) gave the health industry a unique gift buried in a 900+ page rule adoption. The gift? The first comprehensive U.S. regulation delineating the responsible use and oversight of AI used in connection with health care decision-making.
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”).
Virtual and Digital Health Digest, December 2023
Thank you to all who joined us for our December 13 panel titled the “Race to Regulate.” In case you missed it, unpack this year’s pivotal legal challenges impacting the 2023 — and 2024 — digital legal landscape in our Year in Review Pocket Book.
Class Actions Highlight AI-Assisted Payer Denials
As health care payers increasingly rely on artificial intelligence (“AI”) to speed up patient claim adjudication and prior-authorization determinations, providers should be on the lookout for algorithms designed to deny claims with minimal
human oversight. Two putative class action lawsuits filed against Cigna and UnitedHealth in November 2023 allege that the payers’ respective AI models,
Crowell Presents “AI and Health Care: Perspectives from Policymakers and Movers in the Industry”
On November 2, Crowell hosted an in-person roundtable discussion, featuring government officials, industry experts and other stakeholders, to discuss the development of artificial intelligence (AI) and machine learning (ML) systems and tools in the healthcare sector as well as the government’s role in regulating such technology. Policy makers, thought leaders, healthcare innovators, and business executives
World Bank Issues Digital Health Recommendations in Report
On August 18, 2023, the World Bank issued a publication entitled, “Digital-in-Health: Unlocking the Value for Everyone (“World Bank Report”),” which recommends to governments a new digital-in-health approach where digital technology and data are infused into every aspect of health systems management and health service delivery to improve individuals’ health outcomes. The stated goal of
How President Biden’s Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence Addresses Health Care
On October 30, President Joe Biden signed an Executive Order (“EO”) 14110 entitled, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” which establishes a policy framework to manage the risks of artificial intelligence (“AI”), to direct agency action to regulate the use of health AI systems and tools, and to guide AI innovation
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