Archive
Wade Emmert
Office for Civil Rights Reminder HIPAA Flexibilities End May 2023
HHS Office of Civil Rights confirmed that that four Notifications of Enforcement Discretion (“Notifications”) will expire upon expiration of the COVID-19 PHE, which is currently scheduled…
HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care
HHS Office of Civil Rights has proposed changes to HIPAA’s Privacy Rule which would prohibit disclosures to law enforcement related to obtaining or providing abortions. The…
Supreme Court’s False Claims Case Alleges Overbilling of Medicare and Medicaid
Violations of the False Claims Act require a requisite state of “knowledge” a claim’s falsity. To violate the statute, one must have “actual knowledge,” “deliberate ignorance”…
DOJ Settlements Are a Stark Reminder
Arrangements with referring physicians are common in healthcare, but they can be very danagerous if not structured properly. Too often they are used to obfuscate the…
Widespread Third-Party Tracking On Hospital Websites Poses Privacy Risks For Patients And Legal Liability For Hospitals
Web tracking technology has been in the news a lot lately. Most websites use such tools to track users as they navigate through a particular site…
OIG Approves Gift Cards to Promote Patient Compliance with a Preventive Screening Measure
OIG has approved the use of gift cards to incentivize patients to return sample collection kits, provided there are certain safeguards in place: Mailing the gift…
Can Actions Be Considered Remuneration Under the Anti-Kickback Statute?
When discussing the Anti-Kickback Statute (AKS), it’s common to say that “remuneration” can be “anything of value.” That board definition has been called into question by…
FDA to Refuse Medical Device Submissions For Cybersecurity Reasons Beginning in October
Jill McKeon, for Health IT Security: Effective immediately, the US Food and Drug Administration (FDA) will require medical device manufacturers to provide cybersecurity information in their…
FDA Cybersecurity Requirements for Medical Devices Now in Effect
From the HIPAA Journal: On Wednesday, March 29, 2023, the medical device cybersecurity requirements of the $1.7 trillion omnibus spending bill – The Consolidated Appropriations Act,…
A Federal Judge Suspends FDA’s Longtime Approval of an Abortion Pill, but Gives the Government 7 Days to Appeal
Medication abortions typically use two drugs taken together: Mifepristone and Misoprostol. This ruling only affects Mifepristone. The other drug, Misopostol, is still available, but its use…