As stakeholders, legislators and policymakers wrestle with the myriad of issues related to the provision of remote health care, clinical and technological advancements continue apace. What was once an industry focused primarily on the provision of primary care through existing remote platforms is morphing into a highly sophisticated brew of clinical and technological innovation. In that regard, several trends have caught my attention. While these trends may not squarely fall within the accepted definitions of “telehealth”, they are worth noting because they raise many of the same legal and clinical issues with which we currently wrestle in the telehealth space. I am limiting my discussion to three of these trends and will address others in a separate post.
The wearables industry is projected to significantly increase in the next few years. Generally speaking, wearables are devices (which usually include microchips or sensors) that, among other functions, collect data, and track fitness and wellness. A leading research firm projects that the global wearable devices market will reach $37 billion in 2020—a significant jump from $1 billion just a year ago. Moreover, wearable device shipments are projected to grow from about 20 million shipments last year to 135 million by 2018. Wearables are part of a greater trend in which everything is connected to a network—the so-called Internet of Things. There are about 12 billion Internet-connected devices currently in existence worldwide—the equivalent of 1.7 devices for every person. That number will increase to a ratio of 4.3 by 2020 when 33 billion devices will be in use.
Many believe wearables are part of a continuum which will lead to wider use of nanotechnology and implantable medicine. As these devices become more sophisticated, they will be better able to integrate collected data into an individual’s EHR and perform more than basic diagnostic testing.
While wearables are essentially in early development, many legal and regulatory issues may be implicated. Here are a few:
- Data privacy and security (who has access to the data, who owns the data, how long the data will be used, etc.).
- Potential changes to malpractice liability (clinicians having access to more information regarding a particular patient, providers ability to review the voluminous data, etc.).
- Employer issues (wellness programs, ADA concerns, etc.).
These and other legal issues will become more relevant as the wearables sector grows and more sophisticated technological products are developed and deployed. The real lesson here is that the healthcare ecosystem needs to be prepared to balance clinical and legal concerns with clinical and technological innovation. That is a tall order especially given how legislators and regulators have approached the regulation of telehealth over the past few years. Based on that experience, I find it unlikely that policymakers will adjust quickly to the wider use of wearables and the attendant clinical and legal implications that will be brought to bear.
AI, which uses complex computer algorithms to organize unstructured data, is increasingly being used in the healthcare space. Advocates of AI note that it will enable clinicians and researchers to make full use of the voluminous amounts of data that exists in databases (e.g., cancer registries), EHRs, journal articles, diagnostic images, and wearable devices. Through the use of AI, providers may be able to obtain real-time clinically useful information. For example, included among the more popular uses of AI are:
My sense is that the use of AI in healthcare will increase exponentially in the next few years. Many of the same legal and regulatory issues implicated by wearables are relevant here. What may be different, however, is that AI presents a myriad of complex and novel issues that are deserving of more discussion and fall outside the scope of this post.
The Department of Health & Human Services has concluded that only about 40 percent of all adults in need of mental health care actually receive the services. While many are referred for treatment, many barriers exist including costs. It has been estimated, for example, that the median cost of a psychologist’s session is $75.
Text therapy is a recent trend that attempts to address the shortfall. Text therapy, through smartphone apps or websites, allows users to connect to a variety of mental health professionals (such as psychologists, social workers, counselors) via text-based or messaging sessions. While models vary, there are some similarities among the offerings:
- A $25-45 per week subscription fee for unlimited chat.
- Users must complete and submit a questionnaire.
- A mental health professional is assigned to the user (some companies use a mental health professional to essentially triage and match the user with a fellow professional).
- Users can request a different mental health professional than the one who has been assigned.
- Phone sessions are available for additional fees.
Among the legal and regulatory issues raised by the use of text therapy are licensure, scope of practice (minors, emergencies, follow-up care, etc.), data privacy and security, and reimbursement (many plans do not reimburse for the use of this type of therapy). As these types of services evolve, so too will the laws and regulations, albeit slowly.