Page 2 - Enabled Device Software Functions News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Regulating AI: An Overview of Federal Efforts | Rothwell, Figg, Ernst & Manbeck, P C

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management.

White houseDistrict of columbiaUnited statesAndrew solenderAndrew smithMichael atlesonLinam khanElisa jillsonGuardian marJames vincentSenate majority leader chuck schumerMatter of everalbum incNational artificial intelligence research institutesNational institute of standardsNational security commission on artificial intelligenceProgram artificial intelligence rd investments

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding
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Software detailed designSoftware architectural designProgram for medical device submissionsGuidance the agencySoftware architecture designShelf software use in medical devicesPremarket submissions for device software functionsKing spaldingEuropean union medical devices regulationSoftware design specificationDevice software functionsClinical decision support softwareInternational medical device regulators forumSoftware requirements specificationDrug administration staffPremarket submissions

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence | Arnall Golden Gregory LLP

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared.

Device software functionsEuropean unionSubmission recommendationsPredetermined change control planMachine learningEnabled device software functionsDrug manufacturingImpact assessmentModification protocolModification protocol sectionDrug manufacturersArtificial intelligence act

The Nucleus: Life Sciences Regulation and Enforcement Updates | Skadden, Arps, Slate, Meagher & Flom LLP

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key.

United statesLisa millerJoe bidenSophie rebeilJeff shurenLaura ellisOlympu fukushimaElizabethj perkinsSupreme courtOffice of inspectorHuman servicesMeagher flomPublic health service actPilot programCompliance institute keynoteUs department of health

ONC Proposes Sweeping Health IT Certification Program Requirements for Predictive Decision Support Interventions —Featuring FDA-Like Standards | Akin Gump Strauss Hauer & Feld LLP

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed.

Natl coordinator for health infoCommission sectionCertification program updatesClinical decision support softwareHealth insurance portabilityHuman servicesDrug administration staff aprOffice for civil rightsHealth it certification programHealth information technology for economicAgency for healthcare researchHealth it modulesHealth dataAkin gump strauss hauer feldUs department of healthHealth breach notification rule