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

By Jiayan Chen, Lisa Schmitz Mazur, Michael Ryan, Ryan Marcus, Scott Weinstein, Sarah T. Hogan, Vernessa T. Pollard, McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark and Jennifer S. Geetter on February 8, 2018

Posted In Health and Welfare Plans, Privacy and Data Security

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 the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.

We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.

Tags: Chairman Maureen Ohlhausen, data breach enforcement, FDA, Federal Communications Commission, Federal Trade Commission, HIPAA, Medicare coverage and reimbursement, National Infrastructure Advisory Council, SAMD, software as a medical device, Substance Abuse and Mental Health Services Administration, Telephone Consumer Protection Act, US Food and Drug Administration

Jiayan Chen
Jiayan Chen is deeply experienced in the regulatory, transactional and strategic issues that arise when leveraging health information, biospecimens and technology to drive healthcare innovation and quality. She guides stakeholders on privacy compliance and research compliance and in the context of strategic initiatives and collaborations as they seek to harness the power of data, machine learning, DNA sequencing and technologies to develop and deploy new products and solutions and address challenges in healthcare delivery and payment. Read Jiayan Chen's full bio.

Lisa Schmitz Mazur
Lisa Schmitz Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Lisa advises a variety of health care providers and technology companies involved in “digital health,” including assisting clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa helps clients identify and understand the relevant legal issues, and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape. Read Lisa Schmitz Mazur's full bio.

Michael Ryan
Michael W. Ryan advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, drugs, biological products, and clinical laboratory testing services. Read Michael Ryan's full bio.

Ryan Marcus
Ryan B. Marcus maintains a general health care practice. He advises hospitals health systems, and health industry clients on a variety of regulatory and transactional matters, including mergers, acquisitions, affiliations, and joint ventures. Read Ryan Marcus' full bio.

Scott Weinstein
Scott A. Weinstein provides legal counsel on health care regulatory compliance, contracting and transactional due diligence, with a focus on health information privacy and security, Medicare and Medicaid's health information technology and quality reporting requirements, and clinical research regulations. Scott additionally provides legal counsel on federal and state privacy and data protection laws, with a focus on privacy audits and the development of internal and externally facing privacy policies for websites and mobile applications. Read Scott Weinstein's full bio.

Sarah T. Hogan
Sarah Hogan represents companies in the life sciences and digital health industries on structuring and negotiating intellectual property licenses, strategic collaborations and other complex commercial transactions – helping her clients leverage intellectual property assets and collaborate to develop and deliver innovative solutions that improve health and health care. Sarah uses her science background and comprehensive life sciences industry knowledge as an asset to understand critical business concerns and effectively manage complex issues. As a result of the diverse range of clients and transactions she manages, Sarah has in-depth understanding of the implications of each deal on various aspects of the business, including downstream transactions. Sarah is known for her practical approach – focusing on achieving business objectives while balancing legal risks and preserving her clients’ relationship with their partners. Read Sarah Hogan's full bio.

Vernessa T. Pollard
Vernessa T. Pollard advises companies on regulatory, compliance, enforcement and policy matters involving pharmaceuticals, medical devices, health information technology (HIT) and digital health solutions, services and software. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions and other transactions involving Food and Drug Administration (FDA)-regulated products. She also counsels manufacturers, distributors and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety. Read Vernessa Pollard's full bio.

McDermott Will & Emery

Bernadette M. Broccolo
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.

Dale C. Van Demark
With his robust experience in health system affiliations, joint venture transactions, cross-industry collaborations and the development of new healthcare delivery models, Dale C. Van Demark works at the forefront of strategic transactions and digital health matters in the health, life sciences and technology industries. As a sought-after legal, strategic and policy advisor, he’s well-informed on integrating information technology into healthcare and has worked with clients in the realms of delivery of care, life sciences research and development, and artificial intelligence. Dale C. Van Demark serves as a co-chair of the Firm's Digital Health practice. Read Dale Van Demark's full bio.

Jennifer S. Geetter
Jennifer S. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws. Jennifer represents a broad range of clients. Read Jennifer Geetter's full bio.

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

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