Bernadette Broccolo

Bernadette Broccolo

McDermott Will & Emery

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Digital Health Solutions are Key to Success under Health Care Payment Innovations

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held...more

12/21/2016 - Digital Health Healthcare Medical Devices Medicare Access and CHIP Reauthorization (MACRA) MIPS Software

Digital Health’s Perfect Storm of Regulators

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the...more

12/20/2016 - Compliance Digital Health Health Care Providers Innovation

Managing the Transition to Transformation: Digital Health Solutions: Essential Ingredients in Alternative Health Care Delivery and...

INTRODUCTION - Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the...more

11/9/2016 - ACOs Alternative Payment Models (APM) Digital Health EHR Health Information Technologies Healthcare Medicare Shared Savings Program

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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