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McDermott Will & Emery

CMS Issues Guidance on Usage of AI in Making Coverage Determinations

McDermott Will & Emery on

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers...more

Foley & Lardner LLP

Software as a Medical Device (SaMD): Health Care Regulatory Considerations

Foley & Lardner LLP on

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more

Mintz - Health Care Viewpoints

A Tale of Two False Claims Act Settlements Involving EHR Vendors

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

Jones Day

"Meaningfully Useful" Risk Mitigation Strategies for Providers Following the eClinicalWorks Settlement

Jones Day on

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

Bass, Berry & Sims PLC

A Striking EHR Settlement: The DOJ pursues an EHR Vendor for "Causing the Submission" of False EHR Incentive Payment Claims

On May 31, 2017, the U.S. Department of Justice (DOJ) announced a $155 million settlement with eClinical Works (ECW), a nationally-known electronic health records (EHR) software vendor. The settlement arises out of a lawsuit,...more

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