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Health Information Technologies › Regulatory Reform

McDermott+

Health Information Technology Policy Under the Trump Administration

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Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

Health Care Compliance Association (HCCA) on

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Skadden, Arps, Slate, Meagher & Flom LLP on

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

Akerman LLP - Health Law Rx

Health Apps Beware: FTC Clarifies Health Breach Notification Rule with Significant Proposed Changes

Akerman LLP - Health Law Rx on

Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Health Care Compliance Association (HCCA) on

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Wilson Sonsini Goodrich & Rosati

FDA Reduces Regulatory Burden for Certain Medical Image Analyzers

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more

Mintz - Health Care Viewpoints

Strategies to Unlock AI's Potential in Health Care, Part 4: How and When Will Congress Act?

Mintz - Health Care Viewpoints on

The rise of artificial intelligence (AI) developments over the last decade has had profound implications for the health care industry. From IBM’s Watson to lesser known innovations that have flown under the radar, such as...more

Jones Day

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

Jones Day on

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

Moore & Van Allen PLLC

North Carolina Legislative Report

Moore & Van Allen PLLC on

The General Assembly convened for the 2015 legislative session on January 14. Lawmakers returned to Raleigh on January 28 to begin the session in earnest. The MVA Public Affairs Legislative Report on North Carolina will be...more

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