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Chambliss, Bahner & Stophel, P.C.

OCR Finalizes Post-Dobbs HIPAA Regulatory Changes Impacting Health Care Organizations

On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...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

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Gardner Law

Are you Submission Ready? FDA Medical Device Submission Tips & Tricks

Gardner Law on

Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes...more

Knobbe Martens

FDA Publishes Draft Medical Device Cybersecurity Guidance Amidst Continued Cybersecurity Concerns

Knobbe Martens on

On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...more

Hendershot Cowart P.C.

Common Medical Lab Referral & Compensation Arrangements Could Lead to Criminal Charges

Hendershot Cowart P.C. on

EKRA stands for the Eliminating Kickbacks in Recovery Act, and it has become a prominent enforcement tool against fraud in the healthcare and medical testing industries. Although the law was developed in 2018 to help combat...more

McDermott Will & Emery

[Event] 2019 Healthcare Services Private Equity Leadership Forum - October 25th, New York, NY

McDermott Will & Emery on

Among the most active markets in private equity, the healthcare industry is ripe with opportunity for players in the healthcare services arena that can navigate the fast-paced deal environment and complex regulatory...more

McDermott Will & Emery

[Event] 2019 European Healthcare Services Private Equity Leadership Forum - September  26th, London, United Kingdom

McDermott’s annual European Healthcare Private Equity Leadership Forum is a must-attend event for executives from top management teams, health and life sciences companies and providers, private equity, family offices,...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Transformational Artificial Intelligence: Prioritizing AI in Healthcare While Maintaining Legal Compliance

In February 2019, President Trump signed an executive order titled “Maintaining American Leadership in Artificial Intelligence,” also known as the American AI Initiative, that aims to increase the use of artificial...more

Foley & Lardner LLP

Tapping Into the Big Value of Health Care Big Data

Foley & Lardner LLP on

In This Issue: - Executive Summary - Improving Care by Tapping Into the Data Goldmine - Big Opportunities Available in Big Data - Government Programs Supporting the Use of Big Data -...more

Foley & Lardner LLP

Regulatory Challenges Facing the mHealth Industry

Foley & Lardner LLP on

Innovations in health care technology have created unique challenges for developers and investment companies. Among others, changing FDA guidelines, data security, and reimbursement are all substantial issues facing the...more

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