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
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
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
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
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
Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway). According to DOJ, Greenway violated the False Claims Act (FCA)...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
The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more
Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more
The U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) recently released a compendium (Compendium) of its top unimplemented recommendations. The Compendium comprises 25 unimplemented past OIG...more
On January 7, 2016 the Department of Health and Human Services (“HHS”) released a fact sheet and a series of frequently asked questions to help to clarify an individual’s right to access and obtain a copy of his or her health...more
On October 6, 2015, CMS released the final Stage 3 Meaningful Use Rule that, among other provisions, sets forth the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must...more
This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,...more
On November 26, 2012, the Department of Health and Human Services Office for Civil Rights (“OCR”) published a thirty-two page document titled “Guidance Regarding Methods for De-identification of Protected Health Information...more