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.

Read the full Special Report.

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Photo of Bernadette M. Broccolo 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.

Photo of Jiayan Chen Jiayan Chen

Jiayan Chen counsels clients on a range of regulatory and strategic issues that arise in the context of biomedical innovation and data sharing initiatives. She also has extensive experience advising life sciences companies and their collaborators on state and federal “Sunshine” and gift ban requirements. Read Jiayan Chen’s full bio.

Photo of Jennifer S. Geetter 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.

Photo of Sarah T. Hogan 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.

Photo of Lisa Schmitz Mazur 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.

Photo of Vernessa T. Pollard 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.

Photo of Michael W. Ryan Michael W. 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.

Photo of Dale C. Van Demark Dale C. Van Demark

Dale C. Van Demark advises clients in the health industry on strategic transactions and the evolution of health care delivery models. He has extensive experience in health system affiliations and joint venture transactions. Dale also provides counseling on the development of technology in health care delivery, with a particular emphasis on telemedicine. Dale has been at the forefront of advising clients with respect to the globalization of the US health care industry. He advises US and non-US enterprises with respect to the formation of cross-border affiliations and international patient programs. In addition to writing regularly on matters related to his practice, Dale has spoken at numerous conferences around the world on the globalization of health care. Read Dale Van Demark’s full bio.

Photo of Shelby Buettner Shelby Buettner

Shelby Buettner advises pharmaceutical, medical device manufacturers, healthcare technology companies and healthcare providers on FDA regulatory and compliance matters. She regularly counsels clients on regulatory and policy considerations associated with mobile medical technology, telehealth, telemedicine, digital health and clinical research. Shelby assists clients, including academic medical centers and biotechnology manufacturers, with regulatory, transactional and compliance issues related to clinical research, manufacturing and quality issues and legislative initiatives affecting the healthcare industry. Shelby’s transactional practice focuses on advising investors on FDA regulatory and business considerations in pharmaceutical, medical device and clinical research transactions and contractual arrangements. She also assists investors and companies to conduct due diligence on FDA regulatory matters for mergers and acquisitions and other transactions. Read Shelby Buettner’s full bio.

Photo of Ryan Marcus 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.

Photo of Scott Weinstein 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.