Public-health researchers, officials and medical professionals rely on data to track outbreaks, advance research, and evaluate prospective treatments. One critical source of patient data comes from electronic health records (EHRs). EHR data in the U.S. has traditionally been siloed within
Covington Digital Health
Developments and Trends in Digital Health, eHealth and Health IT
Covington Digital Health, published by Covington & Burling LLP, focuses on legal and regulatory developments at the intersection of digital health, biotechnology, and life sciences. The blog covers topics such as regulatory compliance for AI-enabled medical devices, data protection and privacy in clinical trials, FDA policies on digital therapeutics and health technology, and innovations in healthcare data interoperability. It also addresses emerging issues related to artificial intelligence in healthcare, real-world evidence generation, and the evolving regulatory landscape for digital health technologies. The blog serves as a resource for companies navigating complex legal frameworks in digital health and life sciences sectors.
Latest from Covington Digital Health - Page 11
SAMHSA Revises Part 2 Regulations for the Confidentiality of SUD Patient Records
On July 13, 2020, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising the Confidentiality of Substance Use Disorder Patient Records regulations located at 42 C.F.R. Part 2,…
Bipartisan Bill Seeks to Create National Artificial Intelligence Research Resource Task Force
On June 4, 2020, Representatives Anna Eshoo (D-CA-18), Anthony Gonzalez (R-OH-16), and Mikie Sherrill (D-NJ-11) introduced the National AI Research Resource Task Force Act. This bipartisan bill would create a task force to propose a roadmap for developing and…
White House Hosts G7 Science and Technology Ministerial on COVID-19
On May 28, the White House Office of Science and Technology Policy (OSTP) hosted a meeting of the G7 Science & Technology (S&T) Ministers to collaborate on COVID-19 response and recovery. The G7 S&T Ministers emerged from the meeting with…
Recent AI Developments in the Fight Against COVID-19
Client Alert: FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH
The following guidance could be relevant to manufacturers of software as a medical device (SaMD). The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This…
FTC to Consider Changes to the Health Breach Notification Rule
On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”). The request for comment is part of a periodic review process…
NHSX Publishes “Buyer’s Checklist” for AI Solutions
By Joshua Gray
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…
FCC Waives Equipment Authorization Rules for GE Healthcare to Address COVID-19 Supply Chain and Testing Challenges
By Yaron Dori
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…
Germany Establishes a Simplified Procedure for Reimbursement of Digital Health Applications
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.…