Digital Health & Health Information Technology
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Digital Health & Health Information Technology is becoming an integral part of all aspects of the health care sector due to the proliferation of new kinds of health data, the opportunity for greater analytics capabilities, and the demands from payment reform efforts. Health care providers are leveraging technology to identify new opportunities for collecting, exchanging, analyzing, and using information to change and improve the way they provide care. Technology developers inside and outside the health care sector are tapping into new opportunities to meet consumer needs and expectations by providing innovative products and services to enable greater individual engagement and convenience. Health insurers are using technology to leverage data for population health management and value based payment.  There are new and changing regulatory requirements and legislative efforts that attempt to respond to the dynamically evolving technology environment. This can lead to uncertainty for health care providers, hospitals, technology developers, insurers, and data analytics organization as they are responding to changing payment approaches, greater focus on health care outcomes and leveraging technology to improve patient engagement.

As a result, health care organizations and technology companies need a combination of legal advice, strategic counseling, and policy direction on a wide range of issues related to digital health and health information technology. Crowell & Moring is a leader in the cutting edge legal and policy issues associated with the explosive growth of health technology and we have the experience, knowledge, and skills to support these growing needs. Our lawyers have served in high level roles at key government agencies, including the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), Centers for Medicare & Medicaid Services, the United States Patent and Trademark Office, U.S. Food & Drug Administration (FDA), Federal Trade Commission, and as congressional staff for key Republican and Democratic leaders.

Our team is led by a lawyer who served as the first counsel at HHS on health IT working across program offices and directly advising the Immediate Office of the General Counsel who also helped create the ONC and served as the Director of the Office of Policy throughout the 10-year history of the office.

Regulatory Environment

We understand the complex regulatory environment that now surrounds health care providers adopting and using health IT, technology developers designing and selling health IT products and services, and service providers and other entities that are supporting exchange and use of health information. These requirements are being updated regularly through legislative and regulatory changes and our team follows the latest issues in areas of regulation important to health care providers and health IT developers, including:

  • Standards and Certification of Health IT
  • Medicare and Medicaid Payment and Health IT Requirements
  • FDA Oversight of Mobile Medical Applications and Health IT
  • Privacy and Cybersecurity
  • Competition
  • Health IT Safety Electronic Prescribing of Controlled Substances
  • State Law and Policy
  • Fraud and Abuse

Services

In this complex, fast-developing market, combined with the dynamic legal and regulatory environment, we assist clients in responding to, taking advantage of, or driving these changes. We provide legal and policy guidance to organizations that are reacting to new and existing requirements and those that have unique questions and are trying to drive policy or advance new markets for technology in the health care sector.  Our team works with health systems and health insurers that are trying to leverage new technology to improve population health and improve patient engagement, and with data analytics organizations and technology developers who are expanding into the health care sector or developing new approaches to improve health or health care delivery. We advise our clients on a variety of health IT areas, including:

  • Regulatory and Policy Developments
  • Privacy and Cybersecurity
  • Product and Provider Liability
  • Payment and Licensure
  • Intellectual Property
  • Corporate Governance
  • Advertising and Product Risk Management
  • FDA Regulatory Status and Premarket Review Strategies

Key services we offer to clients include:

  • Providing legal and policy advice regarding health IT and privacy to inform strategic decision making and support compliance efforts.
  • Assisting established health care entities to leverage technology to successfully adapt to change, including improving efficiency, managing population health, and engaging consumers.
  • Building coalitions and drive policy on challenging issues, such as privacy in the digital age, mobile health tools, and health information exchange.
  • Assisting innovative entities that are improving health by developing technology or approaches to health care delivery.