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
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 new medical devices and in vitro diagnostic medical devices (“IVDs”) not
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
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.
The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which
NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise). For example, the Guidance highlights:
Yesterday, the Federal Communications Commission (“FCC”) granted GE Healthcare (“GEHC”) a waiver of its equipment authorization rules to allow for the importation, marketing, and operation of certain medical devices that have yet to receive authorization under applicable FCC requirements. The GEHC devices at issue include bedside and wearable patient monitors; telemetry transmitters; antenna infrastructure; wireless
On April 21, 2020, the “Regulation on the Requirements and the Process for the Examination of the Eligibility of Digital Health Applications for Reimbursement by the State Health Schemes” (Digitale Gesundheitsanwendungen-Verordnung – „DiGAV“) came into force in Germany. It is accompanied by an extensive Guidance (Leitfaden) issued by the Medicines and Medical Devices Agency “BfArM”.
Continue Reading Germany Establishes a Simplified Procedure for Reimbursement of Digital Health Applications
Digital health companies are playing an important role in the global response to the COVID-19 public health emergency. For example, the White House Office of Science and Technology Policy issued a Call to Action to the tech community requesting help in answering urgent scientific questions about COVID-19. As readers of this blog are aware, some
Digital health applications that meet certain requirements will be covered by the German state health insurance schemes from 2020. This is one of the elements of the Digital Healthcare Act 2019 (Digitale Versorgung-Gesetz), which we discussed in an earlier post this year and which was approved by the German Parliament in November and
This is the 11th, and final, of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: Why involve a lawyer?