On December 2, 2022, the U.S. Department of Health and Human Services (“HHS”), through the Office for Civil Rights (“OCR”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a proposed rule to implement statutory amendments enacted by
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California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information
On September 28, the governor of California signed into law AB 2089, which expands the scope of California’s Confidentiality of Medical Information Act (“CMIA”) to cover mental health services that are delivered through digital health solutions and the associated
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
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
Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability
The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies. It acknowledges the risk that this could lead to many existing and
German Federal Office for Information Security Publishes Security Requirements for Healthcare Apps
On June 23, 2022, the German Federal Office for Information Security (“Office”) published technical guidelines on security requirements for healthcare apps, including mobile apps, web apps, and background systems. Although the technical guidelines are aimed at healthcare app developers, they
OCR Seeks Comments Related to Recognized Security Practices and Distribution of Civil Monetary Penalties under the HITECH Act
On April 6, 2022, the Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) published a request for information (“RFI”) seeking public comment on implementing certain provisions of the Health Information Technology for Economic and
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
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
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