Publications

HHS again makes HIPAA enforcement-related headlines, but not for the same reason it had in the recent past. At the end of April, HHS issued a “Notification of Enforcement Discretion Regarding HIPAA Civil Monetary Penalties” (the “Enforcement Discretion Notice”) in which it announces reduced annual limits for HIPAA violations based […]

Beginning on April 1, 2019, CMS started using a Preclusion List as a basis for denying claims for Medicare Advantage, Part D and PACE claims. The concept of the Preclusion List was finalized a year earlier in CMS-4182-F, Contract Year 2019 Policy and Technical Changes to the Medicare Advantage Cost […]

At this year’s Health Care Compliance Association Compliance Institute, Joanne Chiedi, Principal Deputy Inspector General of Health and Human Services (“HHS”) spoke about innovation in health care and the important role of compliance, recommending that compliance have “a seat – and a voice – at the innovation table.” Ms. Chiedi […]

Washington is gearing up to be the next state to implement a privacy law, following California’s Consumer Privacy Act (“CCPA”). On March 6, 2019, SB 5376—formally titled as “an act relating to the management and oversight of personal data,” or the “Washington Privacy Act” for short—passed the Washington Senate and […]

Medical devices are subject to numerous regulations and an intensive approval process to verify their safety for patient use–but what about the software that powers these devices? How secure is the software that operates insulin pumps or pacemakers? In addition to the requirement that medical device software meet general Food […]