Bernadette Broccolo

Bernadette Broccolo

McDermott Will & Emery

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Latest Publications


HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

9/9/2015 - Clinical Trials Comment Period Data Security Exemptions HHS HIPAA Human Genome Project Informed Consent IRB Jurisdiction Medical Research NPRM Proposed Regulation Recordkeeping Requirements Scientific Research The Common Rule

New Board Compliance Guidance Prompts General Counsel Focus

Health care general counsel should review, and brief their internal clients on, the new Practical Guidance for Health Care Governing Boards on Compliance Oversight (Guidance), released on April 20, 2015. A joint effort by...more

4/22/2015 - Chief Compliance Officers Health Care Providers Healthcare Internal Audit Functions Internal Controls New Guidance OIG

OCR Issues Final Modifications to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules to Implement the HITECH...

On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more

2/21/2013 - Business Associates Covered Entities Data Breach Data Protection Enforcement GINA HHS HIPAA HITECH Notice Requirements OCR PHI Privacy Rule

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