The explosion in digital health solutions that connect consumers with licensed health care providers (e.g., nurses, nutritionists, physicians) and laypersons who have certain informal training (e.g., wellness guide, lifestyle coach, outreach partner) has the potential to blur the lines between what constitutes the practice of a licensed health care profession and what does not (usually because the service is intended to be merely informational or educational). Why does it matter which side of the line a particular service falls on? If a service is one that is delivered by a licensed health care professional, there are various state laws and regulations that may govern the activity, and different potential causes of action that may apply in the event a consumer/patient is injured in the process.
- If a digital health solution connects a consumer to an individual who is engaged in an activity that is normally performed by a licensed health care professional, state laws and regulations governing health care professionals likely apply.
As background, state professional boards regulate individuals who deliver health care services to the public (e.g., nursing, psychology, medicine, phlebotomy). What falls within the definition of a specific health care service can be very broad and varies state to state.
If an individual is engaged in a regulated health care activity that requires state professional licensure, the individual must generally have the appropriate type of professional license and comply with applicable “scope of practice” requirements of (a) the state in which the provider is located and (b) the state in which the consumer/patient is located at the time of the encounter.
Developers of digital health tools that include a telehealth component may implement the following to confirm provider compliance with scope of practice requirements (among other things):
- Limit providers to only delivering the type and level of services to patients that the individual is licensed to deliver in the state in which the consumer/patient is located.
- Require consumers/patients to sign informed consent forms in advance of using the digital health tool that clearly indicate and have a place for written acknowledgement by the patient.
- Require training for all providers on the supervisory requirements and scope of practice limitations.
- If the consumer is directly interacting with a licensed health care professional about a medical issue, regardless of the medium of communication, there is a presumption that a provider-patient relationship exists, creating a duty of care, in at least a handful of states.
Medical malpractice liability is a risk inherent in any provider-patient relationship. Claims require proof that a provider owed a duty of care to a patient, the provider violated that duty and the violation resulted in patient injury. (B. Sonny Bal, “An Introduction to Medical Malpractice in the United States,” 467 Clinical Orthopaedics and Related Research. 339 (2009)). Generally, vendors of digital health tools stand outside of the provider-patient relationship and will not be directly subject to medical malpractice claims. Nonetheless, digital health tools are often distributed directly to consumers and patients may be confused about the source of the liability. Therefore, vendors should take steps to inform and remind individuals in writing (e.g., consents and terms of use) that the vendor is not a health care provider who owes such a duty to the individual and to emphasize that individuals should consult with a health care provider before and during use of a digital health tool.
Patients and consumers supply health-related information through digital health tools and these tools collect information from various other sources, including information that will be or has the potential to be shared with a provider. Even if the tools’ functional capabilities are not intended to, and do not, play a direct role in the exercise of medical judgment by a provider, even in part, on the basis of that information may result in personal injury. Potential claims might include a breach of an express or implied warranty or a product liability claim based on a defect in the product (e.g., lacking promised features or functionality, defective features or functionality, or production and maintenance of corrupt, inaccurate, incomplete or inaccessible data or reports). Providing clear and explicit disclaimers to patients and consumers in notices, terms of use or consents (or some combination thereof) is an essential means of mitigating and managing such potential liability.
