Telehealth

Nelson Hardiman is proud of its expertise and reputation in the highly dynamic field of telehealth, including being on a short list of the leading law firms in the country with the specialized knowledge and experience to structure, operationalize, and support the growth of telehealth ventures. We are proud of our experience of taking telehealth ventures from the “whiteboard” phase of planning through early stage growth through the entire venture life cycle, including Series A, B, and later funding rounds, public company or private equity acquisition and even going public. While we are true experts in compliance for telemedicine and other telehealth ventures, we offer clients a distinctive level of telehealth regulatory strategy on the pathway necessary for growth and success.

Our experience includes counseling telehealth pioneers, such as Teladoc, Amwell, as well as cutting edge telehealth companies like Lemonaid Health, and mixed telehealth and brick-and-mortar providers like Carbon Health. Teledentistry companies like Byte have relied upon Nelson Hardiman to take them from early stage concept and start-up all the way to acquisition. Many of the most well known brands in telehealth and subspecialties, including telebehavioral health ventures and focused telemedicine modalities have relied upon our unrivalled experience navigating regulatory issues integral to telehealth. We represent telemedical and other telehealth companies from startup to publicly traded companies, and also advise existing brick-and-mortar and institutional providers on regulatory strategy, compliance, and build-out of telehealth services.

Across the nation, telehealth is rapidly evolving and providers must stay current with distinct areas of relevant law, including corporate practice of medicine compliance (including the PC-MSO model), privacy and data security compliance, an understanding of the laws governing distinct modalities of telehealth, supervision, and scope of practice issues, and pharmacy regulatory issues. Few firms combine the depth in both understanding the regulations, agency guidance, and enforcement priorities. The majority of big law firms that claim to provide telehealth expertise are sorely thin on direct experience addressing challenges with state regulators, an area where Nelson Hardiman’s track record of crisis resolution has been invaluable. (It is little surprise that we are routinely brought in as regulatory counsel on telehealth projects by the largest law firms in the country.) Our experience is often the difference maker at all stages in the venture, allowing clients to move quickly while other firms are busy researching issues with which we are already fluent.

The combination of a deep understanding of the telehealth regulatory landscape, enforcement activity and priorities, and what compliance needs to look like throughout the growth of a venture make Nelson Hardiman a compelling choice for telehealth providers. Nelson Hardiman Harry Nelson has been called upon to advise state regulators in evaluating disciplinary issues for health professionals in noncompliant ventures. Although general guidelines have been recommended and there is interest in moving towards national telehealth standards, the legal and regulatory challenges associated with telehealth today typically are highly dynamic across state lines. It is vital to retain experienced counsel in the event of any licensing board accusations or investigations.

Nelson Hardiman has taken dozens of telehealth providers from their starting steps to exit, and is known for its depth of experience in accomplishing its clients’ goals. Whether you are in the planning phases of a telehealth venture or other mobile telehealth platform or looking for new options to provide efficient, on-the-money answers to the most difficult questions, Nelson Hardiman can provide the detailed, proactive counseling and representation necessary to meet your particular business, regulatory, and strategic challenges. Our services span the range of telehealth issues and include, for example:

  • Regulatory Strategy – analyzing risks and opportunities, risk strategy, and growth strategy, including new models of care, emerging modalities, evolving standards, and guiding clients in charting their venture pathway;
  • Regulatory Compliance – guiding clients on corporate practice of medicine, privacy/data security (HIPAA, CCPA), standards of care, modalities of telehealth, FDA requirements, licensing, internet prescribing, Stark and Anti-Kickback, physician oversight, scope of practice and supervision, and other compliance issues, including development of compliance workplans and infrastructure;
  • Regulatory Diligence – navigating the acquisition or funding process, including providing support as needed to address concerns of acquirers, funders, and strategic partners of telehealth ventures, as well as providing regulatory counsel on mergers and acquisitions in support of “deal counsel”;
  • Corporate and Business Transactions – early stage corporate formation and structuring of professional corporations, management service organizations (MSOs), guidance on establishing compliant models, and documentation of transactions;
  • Regulatory Defense – response to Medical Board, Pharmacy Board, FDA, and other regulatory investigations, proactive outreach to regulators, and response to emergent crises relating to telehealth ventures;;
  • Litigation – disputes related to telehealth, including government investigations, enforcement actions, and litigation (e.g. False Claims Act/qui tam whistleblower litigation and general business disputes).