On December 19, 2022, the U.S. Department of Health and Human Services (“HHS”) through the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to adopt standards for certain electronic health transactions. Specifically, the proposed rule would adopt standards for health care attachment transactions (e.g., medical charts, x-rays, provider notes) and electronic signatures to be used in conjunction with health care attachments, and modify the standard for referral certification and authorization transaction. The proposed rule would apply to entities regulated by the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”), and would implement certain requirements of the Administrative Simplification subtitle of HIPAA and the Patient Protection and Affordable Care Act (“ACA”) that require the Secretary of HHS to adopt and update standards for electronic health transactions, code sets, unique identifiers, as well as the electronic exchange for health information.
FTC, HHS, and FDA Update Tool to Help Mobile Health App Developers Understand Legal Requirements
On December 7, 2022, the Federal Trade Commission (“FTC”), along with the U.S. Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA”), announced updates to the Mobile Health App Interactive Tool—a questionnaire designed to help mobile health app developers identify federal laws and regulations that may apply to
Change is Coming for Software and AI Medical Devices in the UK
The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”). On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme
California AG Probes for Potential Bias in Healthcare Algorithms, Federal Attention Continues
Digital health technologies, including algorithms for use in health care, are being developed to aid healthcare providers and serve patients, from use with administrative tasks and workflow to diagnostic and decision support. The use of artificial intelligence (“AI”) and machine learning algorithms in health care holds great promise, with the ability to help streamline care
OIG Issues Advisory Opinion on Digital Program for the Treatment of Substance Use Disorders
On March 2, 2022, the Office of Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) posted an advisory opinion concluding that a digital program for the treatment of substance use disorders would raise minimal fraud and abuse risk. OIG advisory opinions address the application of certain fraud and abuse enforcement authorities
3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT Pandemics Act
On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, respectively) released a “discussion draft” of bipartisan legislation—the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”)—which contains notable provisions related to digital health.
FDA Webinar Provides New Insights on Use of Digital Health Technologies in Clinical Trials
Spurred by the realities of the COVID-19 pandemic, FDA has taken a number of regulatory actions to advance the use of digital health technologies (“DHTs”) in clinical trials. DHTs provide sponsors with opportunities to capture a broader array of information from study subjects than is typically available through traditional study designs. This includes information from
FTC Releases New Health Breach Notification Rule Guidance, Targets Health Apps and Connected Devices
On January 21, the Federal Trade Commission (“FTC”) announced new resources to help companies determine their obligations under the Health Breach Notification Rule (the “Rule”): the Health Breach Notification Rule: Basics for Business, which provides a quick introduction to the Rule, and Complying with FTC’s Health Breach Notification Rule (“Compliance Guidance”), a more in-depth compliance guidance. These resources follow the FTC’s September 2021 Policy Statement, which expanded the Rule’s application to the developers of health apps, connected devices, and similar products, and similarly emphasize the FTC’s continued scrutiny of health technology.
Continue Reading FTC Releases New Health Breach Notification Rule Guidance, Targets Health Apps and Connected Devices
5 Digital Health Issues to Watch at FDA in 2022
As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities. From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in 2022 related to FDA and
U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices
On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).
Purpose
AI