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Health Technology Algorithms Health Care Providers

Robinson+Cole Health Law Diagnosis

Forecasting the Integration of AI into Health Care Compliance Programs

Health care entities maintain compliance programs in order to comply with the myriad changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial...more

Mintz

EnforceMintz — Artificial Intelligence and False Claims Act Enforcement

Mintz on

Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more

ArentFox Schiff

OIG Again Concludes That Online Health Care Provider Marketplace Does Not Violate Fraud and Abuse Laws

ArentFox Schiff on

In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s AI White Paper: To Be or Not to Be, That is the Question

• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more

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