Mobile health technologies for depression present ethical, legal, regulatory challenges
Mobile health technologies for the management of depression come with unique challenges, according to research presented at the American Society of Clinical Psychopharmacology Annual Meeting.
"Our work examines the ethical, legal and regulatory challenges encountered by clinicians and researchers using mobile health technologies in the field of psychiatry,” Efraim J. Keisari, MD, of the department of psychiatry at University of Connecticut School of Medicine, told Healio Psychiatry. “As with other facets of technology, mobile health technologies are growing rapidly. These technologies show great promise and can help researchers and clinicians diagnose, monitor, treat and even predict symptoms of depression, but with any new technology comes questions of privacy, regulation and ethics, among others. As we integrate technology into our medical practices, we must continue to provide our patients with the best care while adhering to the basic ethical principles of medicine.”
Smartphones are common and allow for the collection of objective, real-time data related to depression symptoms, such as fatigue and activity level, using built-in sensors. However, these opportunities are accompanied by challenges and risks, according to Keisari and colleagues. The researchers conducted a literature review on the ethical, legal and regulatory challenges they experienced during their study on the use of passive smartphone-based data to predict depression symptomatology among 182 college students. They divided participants into two groups — depressed or healthy controls. Results showed significant associations between sensory data and interview assessments and depression scores.
In their poster presentation, Keisari and colleagues noted the issues they encountered during the study. These included ensuring participants’ understanding of the granularity and scope of collected data; issues with data transmission and encryption; issues with data storage related to HIPAA protection; individual access to data for analyses; potential data use for other or future purposes; liability, such as timely data review for suicidality; and privacy.
The literature review revealed that there are currently more than 165,000 applications designed for health care, the vast majority of which lack substantial evidence for their safety and efficacy and are not regulated in a meaningful way, according to Keisari. Further, the researchers found that data breaches occur even with safeguards in place, there is often no clear answer regarding data ownership and data collection from bystanders may infringe on third-parties’ autonomy and privacy. Errors that stem from application malfunctions, failure to act on information and misunderstanding or misinterpretation of information by patients all may result in liability issues, according to Keisari and colleagues.
“Our reaction is one of cautious optimism,” Keisari said. “Mobile health technologies can represent a tremendous step forward in the management of psychiatric conditions. These technologies also present challenges that we must examine and address. Our goal must be to work together to develop and implement these technologies in a safe and ethical manner. We should treat mobile health technologies like a new drug/medication and thoughtfully evaluate the risks and benefits. This will ensure that we provide the best care for our patients in a safe, ethical and equitable manner.” – by Joe Gramigna
Keisari EJ, et al. Investigation of mobile health (mHealth) technologies in the management of depression: Ethical, legal, and regulatory challenges. Presented at: American Society of Clinical Psychopharmacology Annual Meeting; May 29-30, 2020 (virtual meeting).
Disclosure: Keisari reports no relevant financial disclosures.