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Digital Health Technologies and Innovations
Published in Kelly H. Zou, Lobna A. Salem, Amrit Ray, Real-World Evidence in a Patient-Centric Digital Era, 2023
Kelly H. Zou, Mina B. Riad, Shaantanu Donde, Joan van der Horn, Tarek A. Hassan
DTx is different from both digital health and digital medicine in that DTx comprises evidence-based “interventions” designed for the purpose of preventing, managing, or treating a particular disorder or health condition. In other words, DTx is like a digital pill, which requires a similar level of clinical and real-world evidence, regulatory oversight, and clearance as it is required for conventional pharmaceutical products (White Paper: Digital Therapeutics). Thus, DTx products are not merely “wellness apps” but are evidence-based specific interventions delivered digitally.
Response to Open Peer Commentaries on “The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine”
Published in The American Journal of Bioethics, 2018
Craig M. Klugman, Laura B. Dunn, Jack Schwartz, I. Glenn Cohen
Many of the commentaries joined an implicit debate about terminology: how to label these new approaches to medicine. We suggested that these technologies fit the definition of digital medicine as described by Shafer and Kigin (2002, 200), and are a subset of the broader category of digital health as described by the Food and Drug Administration (FDA). Other commentaries used terms like surveillance technology, self-acting medical devices (SAMD), eHealth, mHealth, electronic medicine, digital healthcare, digital health, and surveilled compliance. The term digital medicine is currently used by the manufacturer of MyCite and by Proteus Digital Health (the maker of the digital sensor) (Proteus Digital Health 2018). The popular press, meanwhile, is gravitating toward the terms “smart pill” and “digital pill” in reference to this specific melding of medicine and technology. Regardless of the specific term used—we argue that there is no “correct” term at this early stage of development—this product segment is one that is developing rapidly. For example, a digital form of Truvada (also using a Proteus sensor)—a preexposure prophylaxis (PrEP) against HIV infection—is being evaluated for its potential to improve adherence to this medication (Chen 2018). Proteus is also pursuing digital medicine applications for numerous other disease categories, such as tuberculosis and cancer. The potential for digital pills, smart pills, or digital medicine to enhance individuals’ abilities to take their medications as prescribed—thereby providing the best chance of maintaining or improving their health—is clearly of interest to many stakeholders.
Toward digital-based interventions for medication adherence and safety
Published in Expert Opinion on Drug Safety, 2020
Digital medicines or digital health feedback systems (DHFS) include pill bottle devices, and combination of ingestible pills and wearable devices (e.g., skin patch) to enable drug monitoring through wirelessly observed therapy (WOT) [74]. Digital pill bottles (also referred to as digital pillboxes, smart pill bottles, or electronic monitoring) that record the time/date that the bottle is opened have been demonstrated to improve medication adherence [75–77], but do not confirm pill ingestion [78]. Furthermore, other potential disadvantages are cost and extra effort required of the patient to transfer pills and connect to smartphone.
Remote digital monitoring of medication intake: methodological, medical, ethical and legal reflections
Published in Acta Clinica Belgica, 2021
Wim Van Biesen, Johan Decruyenaere, Katerina Sideri, Julian Cockbain, Sigrid Sterckx
In the framework of a clinical trial, the benefit of a digital tracker to the trial investigator is reassurance that the drug has actually been taken by the patient in the trial, which may be perceived as making the trial results more trustworthy. In most trials, the higher cost of the digital pills would be negligible in the context of overall trial costs. However, using a tracking device for the medication in a clinical trial challenges the interpretation of the study results and requires sufficient consideration of transportability and generalizability issues, as well as the question of how attrition due to side effects is handled. These serious concerns regarding the validity and representativeness of randomized controlled trials [30,31], will only be exacerbated by the use of pill intake tracking systems. A digital pill offers the trial operator the possibility to select ‘compliant’ participants based on characteristics identified by the system providers, to limit the results used for regulatory clearance to those from subjects with a high likelihood of actually taking the drug. Companies might do this to speed up completion of trials, as less drop out occurs, and to improve the chances of a positive outcome, as more compliant patients often have better outcomes. However, excluding non-compliant patients from trials seriously hampers the generalizability of findings to the real world and results in an inflated expectation of benefits. Furthermore, it seriously reduces the occurrence of ‘informative drop out’. There is potential information in the fact that patients stop taking a medication, perhaps unpleasant side effects, or perhaps perceived lack of effect. As a consequence, the results of the trial will again not be representative of the effects in the real world [32].