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Technology has the potential to change all aspects of the health care sector, from data analytics to precision medicine to clinical decision support to patient engagement. But the companies creating this digital future face an array of challenges, such as protecting users’ privacy, ensuring their product’s security, and developing a business model that works within a complex regulatory environment.

Crowell & Moring’s Digital Health team helps leading companies and innovators navigate emerging business opportunities and the regulatory challenges that follow.

Responding to a HIPAA Investigation: Looking Beyond the Facts

Where laws are in constant flux, judgment is a necessary skill. When a health care technology company recently experienced a security incident, the company’s local counsel gave it correct information regarding its response—on the face of it, at least. After consulting with Crowell & Moring’s digital health team, we helped our client respond to the subsequent HIPAA investigation based on our deep understanding of the history of the regulations and agency action and reframe its post-crisis strategy. HHS closed its investigation.

Our team consists of health care industry veterans, technology lawyers, and leading former federal government officials who shaped health information technology policy and regulation in the United States, including the founding director of the Office of Policy in the Office of the National Coordinator for Health Information Technology. Our team includes lawyers who have served in senior roles at key government agencies, including:

  • The White House
  • Department of Health and Human Services (HHS)
  • Office of the National Coordinator for Health Information Technology (ONC)
  • Centers for Medicare & Medicaid Services (CMS)
  • Patent and Trademark Office (USPTO)
  • Food & Drug Administration (FDA)
  • Federal Trade Commission (FTC)
  • Republican and Democratic congressional offices

Our firsthand experience on digital health issues—including data use and interoperability, direct-to-consumer applications, telemedicine, health IT safety and oversight, reimbursement, electronic health records, value-based care, and new product and service development—provides clients with unparalleled insight into the competitive landscape and the objectives of regulators and lawmakers. We handle cutting-edge technology issues including artificial intelligence, machine learning, and blockchain applications in healthcare.

As trusted advisors and long-time legal counsel to clients across the industry, we work side by side with executives, engineers, designers, and product managers to help them develop and operationalize business models that align with the regulatory direction, and bring new solutions to the health care marketplace.

We advise clients operating in every area of the health care industry:

  • Technology companies (including start-ups, large corporations, digital health verticals, and other businesses developing health care tools and platforms)
  • Health care providers and accountable care organizations
  • Health plans and managed care companies
  • Medical device manufacturers
  • Pharmaceutical manufacturers
  • Government contractors
  • Venture capital groups, private equity firms, and other institutional and individual investors
  • Industry groups and trade associations

Translating Digital Health Policy into Business Strategy

Innovative Business Strategies

Today’s health care technology developers, service providers, and users extend well beyond traditional silos. Our clients include leading innovative tech companies, electronic health records (EHR) platforms, remote patient monitoring platforms, and information exchanges, among others. We partner with clients to create innovative business strategies and legal solutions for their digital health products, and we advise companies on engagement with international policymakers leading digital health initiatives.

Our lawyers help clients convert complex health care policy into practical business strategies. We understand the goals of digital health regulation—reduced costs, improved population health, and higher quality of care across the continuum—and help companies navigate and shape policy by providing them a roadmap, as well as develop, implement, and manage initiatives that:

  • Create value through the application of existing technologies and the development of new technologies or approaches to health care delivery.
  • Align the goals and interests of product design, manufacturing, marketing, and leadership teams.
  • Leverage technology to better engage consumers and deliver better care and health outcomes.
  • Ensure compliance with health information privacy and data security requirements. 
  • Build coalitions and drive policy on challenging issues, such as mobile health tools and health information exchange. 

Bottom line: we turn concepts into action, complexity into clarity.

Moving the Industry Forward

Our attorneys are helping to lead the charge when it comes to accelerating technology developments, shifting market forces, and evolving federal and state regulatory requirements. We help clients understand the big picture, identify growth opportunities, and navigate risks before they become major business challenges.

Members of our team currently serve or have served as co-chair of the ABA Science and Technology Law Section, a member of the Health Care Information and Management Systems Society (HIMSS) Work Group on Patient Generated Health Data, the Health Data Innovator Privacy and Security Advisory Committee of Academy Health, and the National Medical Device Post-Market Surveillance System Planning Board. We have been quoted in and written articles for publications as diverse as Harvard Business Review, POLITICO Pro, The Hill, Government Contracting Law, NPR Marketplace, Bloomberg BNA, and our own highly regarded Crowell & Moring Health Law blog.

We speak frequently at industry conferences sponsored by HIMSS, the American Health Lawyers Association (AHLA), numerous universities and think tanks, and other organizations.

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The Feds Want You To Freak Out Over TikTok. You Shouldn’t, And They Can’t Ban It Anyway Forbes (July 24, 2020)
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COVID-19 Vaccine Hacking May Prompt Data Security Rethink Law360 (July 24, 2020)
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"Ransomware: What You Need to Know Now," RSA Webinar (July 22, 2020). Panelist: Evan D. Wolff.
Can The U.S. Government Actually Ban TikTok? AdWeek (July 17, 2020)
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Crowell & Moring LLP is an international law firm with more than 500 lawyers representing clients in litigation and arbitration, regulatory, and transactional matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation, as well as its ongoing commitment to pro bono service and diversity. The firm has offices in Washington, DC, New York, Los Angeles, San Francisco, Orange County, London, and Brussels.

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