In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more
Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
Following the frequent and varied ransomware attacks on health care entities over the past few years, the Office for Civil Rights (OCR) published guidance last summer to the health care industry reminding it that a ransomware...more
With health care breaches constantly on the rise, increasing access to electronic health records (EHRs) from mobile devices, and more prevalent “shadow” cloud use, health care organizations are getting a bit of help from the...more
ONC Releases Updated Guide To Privacy And Security of Electronic Health Information ? The Office of the National Coordinator for Health Information Technology (“ONC”) recently released Version 2.0 of the Guide to Privacy and...more