On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The goal of the conference was to take a comprehensive look at all of the business and legal issues that need to be addressed as health care organizations and technology companies are considering innovative strategies using digital health technologies. The conference covered a wide array of digital health topics, including trends in the healthcare Internet of Things, setting up digital health platforms, legislative activity regarding health IT and telehealth, privacy, cybersecurity, and use of digital health technology to support new payment models.

Session 2, “Setting up a Platform for Digital Health,” featured panelists Jodi Daniel (Partner, Crowell & Moring), Bakul Patel (Associate Director for Digital Health, Center for Devices and Radiological Health, FDA), Anna Shimanek (Senior Legal Counsel, CVS Health), Paul L. Uhrig (EVP, Chief Administrative, Legal, & Privacy Officer, Surescripts) and Ronan Wisdom (Managing Director, Accenture Digital).  Key takeaways include:

  • New partnerships are emerging. There is a broad movement among a variety of stakeholders – providers, payors, consumers, technology companies, and the government – toward using digital health to improve communicating with providers and patients’ understanding of their own health. This leads to new opportunities to partner with other organizations and require strategies for doing so effectively from a legal and business perspective.

  • Policy and innovation is not always aligned. Policy is trying to keep up with innovation, but there are gaps and regular updates to address the fast pace of innovation. The federal government, including the FDA and FCC, is working to set the right temperatures, conditions, and structures for digital health platforms. Yet, there are currently varying regulatory requirements (e.g., for apps or mobile platforms) with a lot of grey in terms of what is permitted (or not). The policy and legal structures need to be in place, and there also needs to be coordination among participating organizations to address governance beyond federal policy
  • Growing availability of data poses challenges about use of that data. Digital health is moving healthcare from episodic data to the availability of constant streams of data through things like wearables and mobile health tools. The question is how providers (with the help of technology companies) will translate this tremendous new volume of data into practical applications and benefits, particularly for health prevention and population health management. In addition, companies face difficult new logistics in dealing with digital health devices and other products.
  • Governance is critically important. Companies need appropriate governance around the transfer of information and proper stakeholder engagement to make digital health work.
  • The digital health legal landscape can be murky. The laws are not always caught up with the technology, and it may not be clear how laws, regulations, and guidance apply to a particular product. At the same time, agencies are reacting and providing updated information all the time. Experienced legal counsel is critical to the success of any player in navigating the digital health space.
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Photo of Jodi G. Daniel Jodi G. Daniel

Jodi Daniel is a partner in Crowell & Moring’s Washington, D.C. office and a member of the firm’s Health Care Group, where she provides strategic advice to clients navigating the legal and regulatory environments related to technology in the health care sector. Jodi is the former director of the Office of Policy in the Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS). She served for a decade as the director at the ONC and 15 years at HHS, where she helped spearhead important changes in health information privacy and health information technology to improve health care for consumers nationwide.

For more than a decade, Jodi has been responsible for thought leadership, policy development, and identifying policy drivers for health IT activities within the federal government, and ultimately established the HHS’ national health IT policy. As former director at the ONC, she addressed privacy and security issues to ensure that there was clear guidance on how the initial Health Insurance Portability and Accountability Act of 1996 (HIPAA) rules applied to health IT. Jodi set the strategic direction and set policy on consumer e-health and health IT safety. She is also credited with establishing the ONC’s regulatory capacity and led the development of all ONC regulations on health IT standards and certification.

As the first senior counsel for health information technology in the Office of the General Counsel (OGC) of HHS, Jodi developed HHS’s foundational legal strategies and coordinated all legal advice regarding health IT for HHS. She founded and chaired the health information technology practice group within OGC and worked closely with the Centers for Medicare and Medicaid Services in the development of the e-prescribing standards regulations and the Stark and anti-kickback rules regarding e-prescribing and electronic health records.

Photo of Marisa E. Adelson Marisa E. Adelson

Marisa Adelson is an associate in Crowell & Moring’s San Francisco office, where she practices in the Health Care and Antitrust groups. In her health care practice, Marisa represents managed care payors and provides counseling on regulatory compliance. Marisa’s antitrust practice primarily involves complex antitrust recovery litigation. Marisa has an active pro bono practice and currently represents a client from South Asia seeking asylum in the United States.