By March 2, 2022, HIPAA covered entities (healthcare providers, health plans, and healthcare clearinghouses) must report all 2021 breaches of unsecured PHI that affected fewer than 500 individuals to the Office for Civil Right for the U.S. Department of Health & Human Services (OCR). Covered entities must submit these reports through the HHS web portal,
Matthias Kleinsasser Presents at Austin Bar Association Health Law Section Meeting | The Basics of the False Claims Act, STARK, and Anti-Kickback Statute and Recent Regulatory Developments
On Tuesday, December 15, Matthias Kleinsasser presented at the Austin Bar Association’s Health Law Section meeting. His presentation, titled “The Basics of the False Claims Act, STARK, and Anti-Kickback Statute and Recent Regulatory Developments,” provided a litigator’s perspective on the basics of the False Claims Act, STARK, and the Anti-Kickback Statute, along with a…
There’s No Such Thing as a Free Lunch
There’s no such thing as a free lunch…. This adage is over 50 years old, and the Office of Inspector General for Health & Human Services (OIG) wants to remind doctors that it remains true.
The pharmaceutical and medical device industry continues to woo doctors with invitations to educational speaker programs in high-end restaurants, with golf excursions, or at sporting venues. On Monday, November 16, the OIG issued a new Special Fraud Alert to remind doctors that speaker programs sponsored by pharmaceutical and medical device companies must serve a legitimate educational purpose and must be appropriately tailored to meet a need in the medical community.
The Open Payments Act requires pharmaceutical and medical device companies to report their spending on entertainment. According to Open Payments data, cumulative doctor payments in the three years from 2017-2019 exceeded $2 billion, and the OIG emphasized that this high amount of spending, and its potential to influence the prescribing or ordering habits of targeted physicians, was one of the reasons for this new alert.…
How HHS Information Blocking Regulations Apply to Healthcare Providers
The U.S. Department of Health and Human Services (HHS) recently finalized transformative rules that will give patients unprecedented safe, secure access to their health data. The rules are issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) to implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act). These final rules mark the most extensive healthcare data sharing policies the federal government has implemented, requiring both public and private entities to share health information between patients and other parties while keeping that information private and secure. These final rules became effective as of June 30, 2020. NOTE: Due to the COVID-19 public health emergency, HHS has delayed enforcement until future dates.…
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COVID Recovery – Providing Quality Healthcare and Staying Ahead of the COVID-19 Curve—Complicated!
In this on demand webinar Shareholder Kevin Wood will cover how medical practices’ can stay ahead of the curve in the COVID environment. This presentation is from the MGMA Texas virtual Annual Meeting that took place September 8-11.
Delaware Franchise Taxes are Around the Corner
Startup? Organized in Delaware? Then you likely received a notice from the Secretary of State of Delaware saying you owe thousands (maybe even tens of thousands) in franchise taxes and have to file an Annual Report by March 1, 2020. DON’T PANIC!! There are two ways to calculate franchise taxes, and Delaware defaults to the…
FDA Guidance Clarifies Clinical Decision Support, Machine-Learning, and Other Digital Health Content
In a long-anticipated move, the United States Food and Drug Administration (FDA), on September 26, 2019, published six guidance documents clarifying its scope of authority and enforcement discretion policies with regards to Digital Health Content in light of the questions raised by the 21st Century Cures Act (Cures Act).
In this article, we take a look at the FDA’s draft guidance that proposes a framework of regulating Clinical Decision Support (CDS) Software, including software containing machine-learning algorithms (ML).
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