U.S. Sen. Ron Wyden (D-Ore) said the Critical Medical Infrastructure Right-to-Repair Act of 2020 would allow trained technicians to provide maintenance and repair services for critical medical systems, and would lift restrictions that are impeding essential repairs and maintenance. The bill would insulate repair companies and their customers from copyright liability for provision of service manuals and the breaking of digital locks during repair procedures, and would allow owners and lessees of the equipment to fabricate parts needed to sustain system function. The Medical Imaging & Technology Association (MITA) voiced its “strong opposition” to the legislation, in part because third-party repair and maintenance entities would not be held accountable by the U.S. FDA for compliance with quality systems requirements. MITA executive director Patrick Hope said, the unintended consequences of this legislation would increase the risk to patient safety,” adding that the right to undertake repairs and maintenance “comes with an inherent responsibility to have a well implemented quality management system.”
Sens. Bill Cassidy (R-La.) and Maggie Hassan (D-N.H.) announced legislation that would improve patient matching via electronic health records (EHRs), a response to the need for contact tracing during the COVID-19 pandemic. The legislation is directed toward patient matching between hospitals and other health care clinical settings and the labs that conduct tests for the SARS-CoV-2 virus, and Hassan said the bill “should be included in the next COVID-19 relief package.” S. 4466 has been referred to the Senate Health, Education, Labor and Pensions Committee.