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
On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more
CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more
On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more
On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician...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
The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more
On May 31, 2019, U.S. Attorney Stephen McAllister of the District of Kansas announced a $250,000 settlement with Coffey Health System to resolve a False Claims Act case. The case arose from allegations that the hospital’s...more
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
Blockchain is rapidly becoming the focus of conversations regarding health care disruption, and for good reason. What started out as a means for cryptocurrency is now making waves in a variety of industries, set to...more
As we know, the move away from fee for service reimbursement models is not only intended to reduce costs by no longer paying providers based on the volume of services performed, but is also intended to improve the overall...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
In this edition of our Privacy & Cybersecurity Update, we examine the impact of Brexit on EU data protection, court rulings on cyber insurance policy exclusions and coverage gaps, recent statements from the FTC and the...more
For those of us who work in the privacy and security space this past week has been a whirlwind with focus on the ramifications of the European Court of Justice (ECJ) decision invalidating the EU-U.S. Safe Harbor Agreement....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