Digital Health Technologies: Navigating the Intersections of Innovation and Regulation

Innovations in digital and technology-supported health and wellness solutions have revolutionized the manner in which patients/consumers engage with and manage their healthcare. To take advantage of the transformative potential of these solutions, manufacturers of digital health technologies must consider the legal and regulatory frameworks that will attach to their adoption and use in order to comply (or enable consumers to comply) with a patchwork of regulations, including those that govern the collection, transmission and storage of health information. In addition, manufacturers will want to consider their own downstream need for access to the data generated or obtained by their digital health solutions and develop comprehensive data strategies to address those needs. This presentation will provide various hypotheticals/case studies on the legal and regulatory issues relevant to digital health medical technology companies and will discuss:

  • Current regulatory landscape
  • Privacy and security compliance considerations
  • Patient outreach and the Telephone Consumer Protection Act
  • Standards of practice, quality and other regulations impacting telemedicine
  • Balancing policies and systems to allow for future innovation

 

Participants that will find this webinar most beneficial will be those involved in medical device and digital health technologies companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Compliance
  • Privacy
  • Security

 

Jennifer S. Geetter

 

 

 

 

 

Jennifer S. Geetter
Partner
McDermott Will & Emery

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, including the following:

  • Pharmaceutical, device and biologics companies
  • Health plan, institutional health care provider and other enterprises
  • Mobile app, mHealth, and other digital health technology companies and platform providers
  • Research institutes
  • Informatics, data broker and data aggregator companies

Jennifer assists these clients with a range of projects, including the following:

  • Health Insurance Portability and Accountability Act (HIPAA), Federal Trade Commission (FTC), and state and federal privacy, security and breach response preparedness and response
  • Research compliance, research program structure, and operational and compliance infrastructure
  • Complex research affiliation agreements and arrangements
  • Scientific review and research misconduct proceedings and investigations (internal and with government involvement)
  • Biobanking and registry development and compliance, including emerging issues in the future, unspecified use of biospecimens and genomic data
  • Development and implementation of data-sharing strategies and platforms to achieve business objectives, particularly in connection with biomedical innovation, health care reform, electronic health record implementation and quality assurance requirements
  • Data privacy, data mapping and data use strategies for mobile apps and other mHealth and digital technologies

Lisa Schmitz Mazur

 

 

 

 

 

Lisa Schmitz Mazur
Partner
McDermott Will & Emery

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” – the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the Internet and mobile devices – on the applicable legal and regulatory infrastructure, with a particular focus on telehealth, telemedicine, mobile health and consumer wellness programs. In addition to writing extensively on matters related to her digital health practice, Lisa has spoken at numerous conferences on a variety of digital health topics. She is the co-editor of McDermott’s Of Digital Interest blog, co-chairs the Interstate Collaboration in Healthcare Stakeholder Group and chairs the Illinois Telehealth Law Forum Program Planning Committee.

Lisa also co-leads the Firm’s Digital Health affinity group, which brings together McDermott lawyers from within and outside the Health Industry Advisory Practice Group to develop thought leadership, share information and collaborate on best practices. Lisa also advises hospitals, health systems, skilled nursing facilities, physician practices, commercial payers, consultants and vendors on a wide range of business, legal and regulatory issues.


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