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Department of Health and Human Services (HHS) Software Developers

Snell & Wilmer

HHS Establishes Certification Requirements for Artificial Intelligence and Machine Learning Software Developers

Snell & Wilmer on

As the impact of artificial intelligence on various sectors of the U.S. economy grew in 2023, so did the involvement of regulators and policymakers. One of the most recent — and substantive — regulatory standards is the...more

Rothwell, Figg, Ernst & Manbeck, P.C.

White House AI Order Balances Innovation And Regulation

On Oct. 30, President Joe Biden issued an executive order on safe, secure and trustworthy artificial intelligence. The executive order provides a sprawling list of directives aimed at establishing standards for AI safety...more

BakerHostetler

Steep Penalties for Information Blocking Finalized

BakerHostetler on

On June 27th, Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) posted its final rule (Final Rule), which amends the OIG’s civil monetary penalty (CMP) regulations to implement the...more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Jones Day

Jones Day Global Privacy & Cybersecurity Update | Vol. 21

Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - NIST Evaluates Advances in Face Recognition Software - On November 30, 2018, the National Institute of Standards and Technology ("NIST") published a...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Wilson Sonsini Goodrich & Rosati

HHS Issues HIPAA Guidance for Mobile Health Apps

The U.S. Department of Health and Human Services (HHS) recently issued guidance to help mobile application developers analyze whether the Health Insurance Portability and Accountability Act of 1996 (HIPAA) may apply to them....more

Cooley LLP

Blog: HHS Launches HIPAA Platform for Medical Application Developers

Cooley LLP on

On Monday, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released an online platform designed for use by developers of mobile medical applications (apps). The site allows users to...more

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