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Third-Party Compliance Healthcare

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

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The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Foley & Lardner LLP

Key Takeaways: 7th Annual “Let’s Talk Compliance” Conference

Foley & Lardner LLP on

Editor’s Note: PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was...more

Foley & Lardner LLP

California: AB 1415 and Expanded OHCA Oversight — What Providers, MSOs, and Investors Need to Know

Foley & Lardner LLP on

On February 21, 2025, California introduced AB 1415, a bill aimed at expanding the regulatory oversight of the Office of Health Care Affordability (OHCA). As discussed in our previous blog, certain health care entities are...more

Health Care Compliance Association (HCCA)

BAAs: If and when third parties receiving PHI for research qualify as BAs under HIPAA

A business associate agreement (BAA) is a written contract between a covered entity (CE) and a business associate (BA) that—among other requirements—(1) establishes the permitted and required uses and disclosures of protected...more

Womble Bond Dickinson

Is Your HIPAA Compliance Program Ready for the FTC?

Womble Bond Dickinson on

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

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