Today, Senators Blumenthal (D-CT) and Mark Warner (D-VA) introduced the Public Health Emergency Privacy Act (“PHEPA”) into the Senate. A companion house bill was introduced by Reps. Anna Eshoo (D-CA), Jan Schakowsky (D-IL), and Suzan DelBene (D-WA), which was co-sponsored by Reps. Yvette Clarke (D-NY), G.K. Butterfield (D-NY), and Tony Cárdenas (D-CA). This and similar
On May 1, 2020, the U.S. House of Representatives introduced House Resolution 6666, the COVID-19 Testing, Reaching, And Contacting Everyone (“TRACE”) Act. The resolution, sponsored by Bobby Rush (D-IL) would authorize the Secretary of Health and Human Services to award grants to eligible entities to conduct diagnostic testing for COVID-19 to trace and monitor the
According to a Bloomberg article posted earlier this morning, the U.S. Health and Human Services Department (“HHS”) suffered a cyber attack on its computer systems Sunday night. The attack appears to have been intended to slow the agency’s systems, but was unable to do so in any meaningful way. Just before midnight, the National Security
On December 28, 2016, the FDA’s Center for Devices and Radiological Health (CDRH) released the final version of its guidance addressing “Postmarket Management of Cybersecurity in Medical Devices: Guidance of Industry and Food and Drug Administration Staff”. This guidance applies to any marketed and distributed medical device, including: (1) medical devices that contain software (including
