Health technology oversight growing more complicated as innovation continues

As health information technology (HIT) evolves and the industry increasingly relies on it, the field represents a niche opportunity for young lawyers. At the American Health Lawyers Association (AHLA) Fundamentals of Health Law conference, presenters Ryann Schneider and Sidney Welch emphasized the necessity of understanding both the technology and regulations as well as maintaining close oversight of vendors. This area presents many pitfalls and compliance is difficult, but essential.

Innovations

At the close of the third quarter of 2016, $6.5 billion in digital health deals were recorded. Clinical operations are finding more uses for technology, as providers use telehealth for specialty consults, chronic care management, monitoring, and diagnosis while patients continue to rely on personal health applications and wearables. These innovations require continued development of oversight strategies.

Statutes and regulations

One challenge for compliance is understanding the changing (and conflicting) rules surrounding telemedicine. CMS has issued and updated telemedicine regulations for Medicare, while Medicaid reimbursement differs between the states. States have also implemented various non-payment laws, such as the definitions of a valid telemedicine encounter and requiring a full license to practice medicine in the state in which the patient is located. There are also intellectual property considerations, as well as dealing with a long list of regulatory agencies from the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ) to the Federal Trade Commission (FTC) and Internal Revenue Service (IRS).

Vendors

When health care entities hire technology vendors, each side has a different level of understanding and priorities. Health care customers are particularly sensitive to safety, outcome commitments, and security than other technology customers, and often overestimate the time and resources required for projects. Vendors are experts on their technology, and have a better idea of the partnership required to successfully implement sophisticated projects.

The speakers noted that counsel does not have to understand the nuts and bolts of the technology, but emphasized the need for a team comprised of both business and tech experts to ensure that all bases are covered. Additionally, if in-house counsel focuses on regulatory understanding, outside technology or intellectual property (IP) counsel can supplement with specialized expertise.