J Korean Med Sci.  2020 Nov;35(45):e373. 10.3346/jkms.2020.35.e373.

Apprehensions about Excessive Belief in Digital Therapeutics: Points of Concern Excluding Merits

• Kim HS

• KMID: 2508802
• DOI: http://doi.org/10.3346/jkms.2020.35.e373

Abstract

Digital therapeutics (DTx), like drugs or medical devices, 1) must prove their effectiveness and safety through clinical trials; 2) are provided to patients through prescriptions from doctors; and 3) may require the approval of regulatory agencies, though this might not be mandatory. Although DTx will play an important role in the medical field in the near future, some merits of DTx have been exaggerated at this crucial juncture. In the medical field, where safety and effectiveness are important, merely reducing the development time and costs of DTx is not advantageous. The adverse effects of DTx are not yet well-known, and will be identified eventually, with the passage of time. DTx is beneficial for the collection and analysis of real-world data (RWD); however, they require new and distinct work to collect and analyze high-quality RWD. Naturally, whether this is possible must be independently ascertained through scientific methods. Depending on the type of disease, it is not recommended that DTx be prescribed, even if the patient rejects conventional treatment. Prescription of conventional pharmacotherapy is often necessary, and if the prescription of DTx is inadequate, the critical time for initial treatment may be missed. There is no basis for continuing DTx use by patients. Rather, the rate of continuity of DTx use is extremely low. While many conventional pharmacotherapies have undergone numerous verification and safety tests over a long time, barriers to the application of DTx in the medical field are lower than those for conventional pharmacotherapies. Considering these reasons, except for certain special cases, an approach to DTx is needed that complements the prescription of conventional pharmacotherapy by the medical staff. When DTx are prescribed by doctors who clearly know their advantages and disadvantages, the doctors' expertise may undergo further refinement, and the quality of medical care is expected to improve.

Keyword

Devices; Medicine; Patients; Physicians; Prescriptions

Figure

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  Fig. 1 Digital healthcare and digital therapeutics.DTx = digital therapeutics.

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