Bernadette M. Broccolo Bernadette M. Broccolo

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  Bernadette M. Broccolo has been counseling health industry organizations for more than 37 years on leading-edge health industry relationship formation and realignments. Her areas of concentration include privacy, technology contracting, corporate governance, human subject protection and federal taxation of exempt organizations. Bernadette speaks and writes frequently on emerging health care topics of importance to her clients and the industry. Read Bernadette Broccolo's full bio.

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018


By , , , , , , , and on Jan 12, 2018
Posted In Advertising & Marketing, Big Data, Cloud, Consumer Protection, Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, Mobile Apps, Telehealth

Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing...

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Upcoming FTC Workshop on Informational Harm | Next Brushstrokes on the FTC’s Consumer Privacy and Security Enforcement Canvas


By and on Oct 25, 2017
Posted In Consumer Protection, Cybersecurity, Data Privacy, Telehealth

On September 29, the Federal Trade Commission (FTC) formally announced a December 12th workshop on informational injury—the injury a consumer suffers when information about them is misused. The workshop will address questions such as, how to characterize and measure such injury and what factors businesses and consumers should consider the benefits and risks of collecting,...

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What You Need to Know about Changes to the Common Rule


By , , , and on Feb 10, 2017
Posted In Data Privacy, General Interest, Uncategorized

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the...

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


By , and on Dec 20, 2016
Posted In General Interest, Mobile Apps, Telehealth

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 devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is...

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Digital Health’s Perfect Storm of Regulators


By , and on Dec 19, 2016
Posted In General Interest, Telehealth

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 numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been...

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