On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a complement and counterpart to the breach notification requirements...more
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more
On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...more
Two divisions of the U.S. Department of Health and Human Services (HHS) – the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) – released the "21st Century Cures Act:...more
On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more
Florida has a new law as of July 1, 2023 relating to the storage of certain health records. The newly enacted Florida Statutes section 408.051 creates the “Florida Electronic Health Records Exchange Act.” The Act states in...more
The Anti-Kickback Statute (AKS) protects healthcare beneficiaries from the influence of money in their medical decision-making. Overall, the AKS criminalizes renumeration “intended to induce patient referrals or influence the...more
On December 10, 2020, the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR) collaborated on announcing proposed HIPAA changes, intended to “empower patients” and “improve coordination of...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
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) each published a final rule (collectively, the Final...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
Aimed at enabling greater patient access and mandating interoperability, recent Final Rules from the Office of the National Coordinator for Health IT (“ONC”) and the Centers for Medicare and Medicaid Services (“CMS”) have put...more
Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more
A patient asks her doctor to send her test results to an app the patient has downloaded on her phone. The doctor worries that the app is not secure and that the patient might not understand the security risks. What should...more
The Centers for Medicare & Medicaid Services (CMS) requires all hospitals to meaningfully use certified electronic health record technology (CEHRT) as part of the Medicare Promoting Interoperability Program. Eligible...more
Editor’s Note: As states face the challenges of the COVID-19 crisis, information technology (IT) is an essential tool to support access to health coverage and the safe and effective evaluation, testing and treatment of...more
On March 9, 2020, the U.S. Department of Health and Human Services (HHS) published final rules to implement the information blocking prohibitions of the 21st Century Cures Act (Information Blocking Rules). The Information...more
The Centers for Medicare & Medicaid Services (CMS) published its highly anticipated final rule aimed at enhancing interoperability and increasing patient access to health information. CMS’s final rule will require hospitals...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
Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system....more
Electronic prescribing (“e-prescribing”) allows health care providers to submit prescriptions to a pharmacy electronically, using a secure software system. E-prescribing increases patient safety, security, and efficiency...more
Governor Desantis recently signed House Bill 831, which will require certain healthcare practitioners to “electronically transmit prescriptions”. Unfortunately, the legislature left this term undefined, creating some...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
Healthcare in the United States is at a crossroads, with technology, new market “disrupters,” and seemingly intractable problems converging. At least that was the central theme we observed at the annual meeting of the...more
Greenway Health LLC, a Tampa-based developer of electronic health records (EHR) software, recently agreed to pay $57.25 million to resolve False Claims Act (FCA) allegations that it overstated the capabilities of and failed...more