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.

Consumer Demand in Digital Health Data and Innovation


By on Feb 28, 2020
Posted In Big Data, Data Transfers/Safe Harbor/Privacy Shield, General Interest

Digital health companies are producing increasingly innovative products at a rapidly accelerating pace, fueled in large part by the expansive healthcare data ecosystem and the data strategies for harnessing the power of that ecosystem. The essential role data strategies play make it imperative to address the data-related legal and regulatory considerations at the outset of...

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US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence


By and on Jan 17, 2020
Posted In Big Data, Consumer Protection, Data Privacy, Telehealth

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory approaches to reducing barriers to the development and adoption of artificial intelligence (AI) technologies. Implementing agencies are agencies that conduct foundational research,...

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Blazing New Trails in Health Care and Technology Innovation Ventures


By and on Jun 19, 2018
Posted In Big Data, General Interest, Telehealth

As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and investment among stakeholders or all sorts. Health systems and other institutional providers are playing a more active investment role in the commercialization...

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Live Webinar: Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors


By , , , , , , , , and on Jun 8, 2018
Posted In Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, General Interest, Mobile Apps, Telehealth

Join McDermott next Wednesday for a live webinar on the unique considerations in developing and procuring AI solutions for digital health applications from the perspective of various stakeholders. We will discuss the legal issues and strategies surrounding: Research and data mapping essential to the development and validation of AI technologies Protecting and maintaining intellectual property...

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Surfing “Tech’s Next Big Wave”: Navigating the Legal Challenges in Digital Health


By and on May 4, 2018
Posted In Big Data, Consumer Protection, Data Privacy, Mobile Apps

Fortune’s April 2018 cover story, “Tech’s Next Big Wave: Big Data Meets Biology,” conveys loudly and clearly that technological innovation is transforming the health care continuum—changing the way care is delivered, as well as how patients manage their ongoing health—and as patient demand for health innovation increases, more companies seem eager to hop on the...

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Order now: The Law of Digital Health Book


By , , , , , , , , , , , , and on Mar 20, 2018
Posted In Big Data, Cloud, Consumer Protection, Data Privacy, General Interest, Telehealth

Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA. Visit www.mwe.com/lawofdigitalhealth to order this...

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Does GDPR Regulate My Research Studies in the United States?


By , , , and on Feb 7, 2018
Posted In Big Data, Consumer Protection, Data Privacy, Workplace Privacy

The General Data Protection Regulation (GDPR) establishes protections for the privacy and security of personal data (Personal Data) about individuals in the European Union (EU) single market countries, and potentially affects the clinical and other scientific research activities of academic medical centers and other research organizations in the United States. This On the Subject includes...

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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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