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Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - July 15th - 18th, Charlotte, NC

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 20, Number 11. Privacy Briefs: November 2020

Report on Patient Privacy 20, no. 11 (November 2020) - HHS Office of the National Coordinator (ONC) for Health Information Technology (ONC) is giving health care organizations more time to meet new rules on information...more

Baker Donelson

Regulatory Sprint: HHS Proposes Expansion of Protections for EHR and Cybersecurity Donations

Baker Donelson on

In furtherance of its goals of expanding the adoption of electronic health records (EHR) and improving security through the use of cybersecurity technology, the Department of Health and Human Services (HHS) has proposed...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...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

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