Digital technologies and smart devices are now used in every aspect of our lives. Further innovation in the digital health realm is growing and has the potential to reduce inefficiencies in the health care system by sharing health data with providers, decreasing costs related to unnecessary health care visits and improving patients’ quality of life and clinical outcomes by better tailoring treatment to the individual’s health needs.1,2
Digital tools, such as mobile health (mHealth), health care wearable devices, health information technology, and telehealth/telemedicine, can give health care providers a more longitudinal view of a patient’s health through access to their health data.1-4 These tools can act as extenders for the clinician to the patient’s home.2 By supplying real-time data, patients do not have to wait for medical provider visits or laboratory test results to identify or prevent potential problems before they become severe.1,2
Clinical Applications
Clinically, there are a variety of applications and software systems that support provider clinical decision-making, including artificial intelligence, machine-based learning, and telehealth. These digital products can be used independently or in tandem with remote or in-person clinician-delivered therapy or be paired with medications, devices, and other therapies for conditions related to mental health, the endocrine system, the respiratory system, the digestive system, blood disorders, and nutrition and metabolic diseases.4,5
These technologies directly affect disease state measures and clinical outcomes, with the potential to expand access to safe, confidential, and effective medical treatments. Additionally, these technologies may help patients with previously untreated or undertreated conditions gain access to therapies as well as extend clinicians’ ability to care for patients and close gaps in care.1,4-6 Because of their accessibility, record of improving outcomes, ability to integrate into care management workflows, delivery of real-world insights, and increased reimbursement by payers, digital therapeutic products are becoming critically important tools for clinicians.7
Important Health Policy
The Access to Prescription Digital Therapeutics Act of 2023 provides for Medicare and Medicaid coverage of prescription digital therapeutics (eg, software applications that are used to prevent, manage, or treat medical conditions). The Centers for Medicare & Medicaid Services must establish a Medicare payment methodology for payments to manufacturers that considers certain factors (eg, ongoing use), and manufacturers must report specific information about private payers subject to civil penalties.7 Once established, appropriate policy and payments have the potential to expand the use of telehealth/telepharmacy broadly.7
Evidence
Digital health technologies go through multiple evaluations in their product life cycle, including both clinical and economic research. These data are used to evaluate product safety, effectiveness, real-world use, implementation, value assessment, and therapy optimization.
When developing a digital health product, manufacturers must have regulatory oversight and clinical premarket evaluations to secure regulatory clearance. Clinical trials and economic evaluations are usually required for initial payer assessments, coverage, and reimbursement. In clinical practice, clinicians want to see a combination of data from clinical trials and real-world data to help determine direct patient care and clinical decision-making.
Regulation and Cybersecurity
About the Authors
Craig Kimble, PharmD, MBA, MS, BCACP, is director of experiential learning, manager of clinical support services, and associate professor in the Department of Pharmacy Practice, Administration, and Research at Marshall University School of Pharmacy in Huntington, West Virginia.
Thomas L. Pile, PharmD, CDCES, is clinical assistant professor in the Department of Pharmacy Practice, Administration, and Research at Marshall University School of Pharmacy in Huntington, West Virginia.
Alberto Coustasse, MD, DrPH, MBA, MPH, is director of the Health Informatics Program in the Management and Healthcare Administration at the Lewis College of Business at Marshall University in Huntington, West Virginia.
Mobile health devices and applications that collect patient data, create and share patient information, and diagnose, cure, or treat a medical condition are subject to FDA regulation and cybersecurity requirements, Federal Trade Commission regulation, Health Insurance Portability and Accountability Act requirements for health care providers, and other regulations.1,3 There are 3 classes of health devices, with Class I being the least regulated and Class III being the most regulated. These devices must comply with premarket design requirements for systems and postmarketing security plans.
There are also a variety of state laws that aim to protect patients and their information. In 2019, the World Health Organization developed guidelines for the use of digital health to strengthen health systems, noting the importance of security and protection of patient data.4,6,7
Final Thoughts
Future development in digital health will look to expand its use to make health care delivery more integrated, reliable, and mainstream. Through telemedicine, telepharmacy, and integrated mHealth platforms, patients and providers can share and receive information faster while supporting better-informed clinical decision-making. The future remains bright.
References
1. What is digital health? FDA. September 22, 2020. Accessed March 30, 2024. https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health
2. What is telehealth? Center for Connected Health Policy. Accessed March 31, 2024. https://www.cchpca.org/what-is-telehealth/
3. The basics: mHealth and the FDA. Center for Connected Health Policy. Accessed March 31, 2024. https://cchp.nyc3.digitaloceanspaces.com/2021/04/mHealth-and-the-FDA-final.pdf
4. Global strategy on digital health 2020-2025. World Health Organization. Accessed March 30, 2024. https://iris.who.int/bitstream/handle/10665/344249/9789240020924-eng.pdf
5. Low CA. Harnessing consumer smartphone and wearable sensors for clinical cancer research. NPJ Digit Med. 2020;3:140. doi:10.1038/s41746-020-00351-x
6. Abernethy A, Adams L, Barrett M, et al. The promise of digital health: then, now, and the future. NAM Perspect. 2022;2022:10.31478/202206e. doi:10.31478/202206e
7. 2021 Digital Health Rx Summit: Thought Leaders Assembly. Presented at: American Pharmacists Association 2024 Annual Meeting & Exposition; March 22-25, 2024; Orlando, FL.
