Clinical Research: Phase 1 - Phase 4

Digital Disruption in Dermatology: The Role of mHealth Technologies in Clinical Care and Clinical Research

In a fast-paced digital world, healthcare has had to adapt to better serve consumers who increasingly prefer the convenience of web- or app-based services to in-person assistance. Mobile health (or mHealth) solutions provide increased access to care, making it easier for patients to receive care and for healthcare professionals to deliver that care.

Visual assessments are a critical component of evaluation and diagnosis for healthcare professionals who treat dermatological conditions. Advancements in medical technology that enable the capture and transmission of high-definition digital images have opened the door for dermatology mHealth programs—and these same technologies have the potential to radically change dermatology trial designs going forward.

Lowering the cost of care and improving outcomes

Digital disruption in the dermatology field is happening on several fronts. In addition to improved image capabilities, new tools are helping patients build knowledge about their healthcare conditions and understand their medical histories. Online interactions empower and inspire patients to take control of—and responsibility for—their health through increased and ongoing self-management thanks to digital tools that enable them to monitor their disease, obtain information, and interact with healthcare professionals.

The benefits of dermatology mHealth options extend to both patients and providers and include:

  • Reduced wait times: Digital health assessments make time spent scheduling, traveling, and waiting a thing of the past. In many cases, response times may be as short as 24 hours. In addition, mHealth tools allow patients to follow up in real time from the convenience of their homes.
  • Reduced risk of contagion: Such as during the COVID-19 pandemic.
  • Lowered costs: Dermatologists embracing the digital format incur lower costs, such as physical office expenses, and these savings can be passed on to patients.
  • The same level of care with increased access and improved patient satisfaction and outcomes: mHealth is adapted to the support of chronic patients daily and facilitates the follow-up by health professionals. A study presented at the American Academy of Dermatologists showed that patients receive at least the same level of care from telehealth as in-office examinations. Conducted at the University of Southern California’s Keck School of Medicine, the 12-month study compared the results of two groups of 150 psoriasis patients and found that telehealth patients enjoyed better outcomes than their in-office counterparts. Lead researcher April Armstrong, M.D. told MedPage Today, “We know that a lack of regular access to dermatology providers results in poor health outcomes. And when we think about the future, we know that after 2020, there will be more people over the age of 65 than under the age of 5, which means the population is continuously growing, and there is a continuous need for dermatology and dermatology providers.” 

Enabling decentralized clinical trials

Beyond the clinic, mHealth technologies are poised to transform dermatology clinical trials. Participating in a clinical trial can be a burden—from travel time and wait time to lost productivity at work or school, study participation often represents a significant commitment. Technology can help sponsors overcome many barriers patients face when deciding whether or not to participate in a clinical trial. With webcams, uploaded images, and other emerging technologies, individuals may no longer need to travel to a doctor’s office or clinical research facility to participate in a clinical trial.

The COVID-19 pandemic accelerated the adoption of digital solutions worldwide. As a result, hospitals, medical facilities, and clinical research organizations had to adapt during the pandemic at a previously unimaginable pace and scale to protect patients, healthcare workers, and clinical research professionals. Digital technologies also became critical in the fight against the ongoing COVID-19 pandemic.

Decentralized clinical trials—also known as virtual or site-less clinical trials—are still a relatively new method of collecting safety and efficacy data from clinical trial participants. These trials are on the rise with the drive to lower research and development costs while improving the patient experience. Through a combination of advanced technologies—apps, wearable sensors and other monitoring devices—sponsors can design studies and social engagement platforms that enable them to conduct every stage of a clinical trial remotely, including recruitment, informed consent, education and counseling, and measurement of clinical endpoints and adverse reactions.

Overcoming barriers to adoption of dermatology mHealth technologies

Despite the benefits, there are barriers to widespread adoption of dermatology mHealth technologies in office settings and clinical trials, particularly in the area of patient perception. The COVID-19 pandemic highlighted a widening ‘digital divide’ that risks leaving behind the elderly and socially disadvantaged due to lack of technological support, lack of access, or cost of equipment.1 In addition, liability, reimbursement, and cybersecurity issues are under consideration, as cyber-attacks on hospitals are on the rise. The transfer of personal health data is fueling debates over who owns and controls that data, raising questions over individuals’ rights to privacy.2

Many issues related to training can be addressed through continuing education and awareness around these new technologies. Electronic files are already commonplace in healthcare, and the security of digital dermatology platforms is consistent with industry-wide record-keeping protocols. Referrals for biopsies can be made through digital platforms, and the shortened dermatologist response times can improve early intervention. Finally, digital paper prescriptions have primarily been replaced, and mHealth resources can digitally send prescriptions to local pharmacies.

From a regulatory perspective, the FDA has issued guidance relevant to digital health and clinical research:

The FDA also launched a precertification pilot program (FDA Pre-cert) intended to help the agency determine the key metrics and performance indicators for assessing the safety and effectiveness of digital health software technologies.3

The European Commission has been building a mHealth Digital Service Infrastructure to allow exchanges of e-prescriptions and patient summaries between cross-border healthcare providers since 2019, intending to have all the other EU countries on board by 2025. In the longer term, the Commission is working towards establishing a European electronic health record exchange format that is secure and accessible to all EU citizens. The second priority of the European Commission is to tap into the considerable potential of health data to support medical research, disease prevention, and personalized healthcare. Their third priority is strengthening European citizen empowerment and individual care through digital tools.4

[1] BMC Public Health. Barriers and facilitators to the use of e-health by older adults: a scoping review. Available at

[2] European Parliamentary Research Service. The rise of digital health technologies during the pandemic. Available at

[3] U.S. Food and Drug Administration. Digital Health Software Precertification (Pre-Cert) Program. Available at

[4] European Commission. eHealth: Digital health and care. Available at