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Covered Entities Medical Devices

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Health Care Compliance Association (HCCA)

2022 Outlook: More Dangerous Ransomware Coupled With Inadequate Security Practices

Report on Patient Privacy 22, no. 1 (January, 2022) - As the COVID-19 pandemic enters its third year, real “security fatigue” with pandemic-related issues will combine with cybercriminals’ increasingly sophisticated...more

Goodwin

Qualifying for Immunity Under the U.S. PREP Act During COVID-19

Goodwin on

As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more

Poyner Spruill LLP

First HIPAA Settlement Involving Wireless Health Services Provider

Poyner Spruill LLP on

We have previously written that the Internet of Things continues to spawn new cybersecurity and privacy concerns. These vulnerabilities have already served as plot devices for shows such as Homeland. Now, the U.S. Department...more

Sherman & Howard L.L.C.

Healthcare Advisory: HHS Announces First Settlement with a Wireless Health Services Provider

On April 24, 2017, the Department of Health and Human Services, Office of Civil Rights (“OCR”), announced its first settlement with a wireless health services provider, CardioNet, Inc., for alleged violations of the Health...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Knobbe Martens

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

Knobbe Martens on

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

Faegre Drinker Biddle & Reath LLP

Fitbit Agrees to Sign Business Associate Agreements and Take on HIPAA Compliance

Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more

Sheppard Mullin Richter & Hampton LLP

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

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