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HHS Health Care Cybersecurity Performance Goals: Proposed Incentives, Penalties and Compliance Standards | Mintz - Health Care Viewpoints

As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity...

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FDA Warning Letter Is a Stark Reminder that if You Claim Your Product Is RUO, it Has to Be RUO | Mintz - Health Care Viewpoints

In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S....

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A Mintz Health Care Roundtable: Current Trends in State Health Care Transaction Review and What to Expect in 2024 | Mintz - Health Care Viewpoints

States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently,...

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FDA Needs a New Approach to AI/ML-Enabled Medical Devices | Mintz - Health Care Viewpoints

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital...

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New Mexico's Health Care Consolidation Oversight Act: An Overview | Mintz - Health Care Viewpoints

On March 1, 2024, New Mexico joined a growing number of states in enacting legislation that increases oversight of certain health care transactions. Senate Bill 15 (S.B. 15), which adds...

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ARPA-H Commits $100 Million to Accelerate Women's Health Research through Sprint for Women's Health | Mintz - Health Care Viewpoints

ARPA-H Commits $100 Million to Accelerate Women's Health Research through Sprint for Women's Health | Mintz - Health Care Viewpoints
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Quality System Harmonization Is Here, But with Small Benefit to Device Industry | Mintz - Health Care Viewpoints

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the...

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CMS Announces New Model for the Delivery of Integrated Behavioral and Physical Health Care | Mintz - Health Care Viewpoints

With the goal of enhancing health care quality and outcomes for individuals with moderate to severe behavioral health conditions and substance use disorders (SUD), the Centers for...

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Health Care Privacy and Security In 2024: Six Critical Topics to Watch | Mintz - Health Care Viewpoints

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages...

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HHS, ONC HTI-1 Final Rule Introduces New Transparency Requirements for Artificial Intelligence in Certified Health IT | Mintz - Health Care Viewpoints

The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on...

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