On September 15, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced five new settlements relating to enforcement of HIPAA’s right of access rule. Under HIPAA, patients have the right to timely access to their medical records, as recently discussed here.

A HIPAA covered entity must respond to a patient’s

Amazon recently introduced the Halo fitness tracker, its first entry into the health wearables market currently dominated by Fitbit and the Apple Watch. Amazon’s previous efforts to move into the healthcare industry have included the acquisition of online pharmacy PillPack in 2018, the mysterious Haven initiative with Berkshire Hathaway and JPMorgan Chase, and various other

The U.S. Department of Justice (DOJ) announced on August 27 that New Jersey-based Konica Minolta Healthcare Americas Inc. agreed to pay $500,000 to resolve allegations that its former subsidiary, Viztek LLC, misrepresented the capabilities of its electronic health records (EHR) software, which caused users of the software to file false claims with the federal government.

After a long quiet period, the second HIPAA settlement to be announced by the U.S. Department of Health and Human Services (HHS) in an orchestrated one-two punch was far more costly to the second violator. Lifespan Health System Affiliated Covered Entity paid $1,040,000 to HHS’s Office for Civil Rights (OCR) in June for failing to

The U.S. Department of Health and Human Services (HHS) announced on July 23 that Metropolitan Community Health Services (Metro) paid $25,000 to HHS’s Office for Civil Rights (OCR) to resolve HIPAA violations. Metro, a Federally Qualified Health Center, operates two multidisciplinary medical clinics in eastern North Carolina under the name of Agape Health Services.

Metro

The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion, of which about $2.5 billion was returned to the Medicare trust fund. The recoveries included judgments and settlements from fraud

Eric Fader, Jeff Kaiser, Chris Kutner, Ada Kozicz and Ben Malerba are authors of the newly released book, “The Federal Anti-Kickback Statute and Safe Harbors: A Practical Guide.”

Published by the American Bar Association, the book covers all safe harbors currently in place, as well as the interplay between the Anti-Kickback Statute (AKS) and other

Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and Garmin (previously discussed here) have all announced research partnerships with academic and clinical institutions to expand their businesses from the “exercise and fitness” market into healthcare

Several of the provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) will help people with substance use disorders and the healthcare professionals who care for them. The Substance Abuse and Mental Health Services Administration will receive $425 million to address mental health and substance use disorder needs as a result of

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law on March 27, made some substantial changes to the confidentiality rules for substance abuse and mental health records to bring them in line with HIPAA confidentiality rules. Among the changes, a covered entity or business associate may now use or disclose substance