Santoro (Mario Negri), ‘digital medicine is important but there are critical issues’

2023-04-27 10:21:26

“Digital medicine is an increasingly established reality and, between successes and criticalities, there are various current applications and possible developments for the future”. Eugenio Santoro, a researcher at the Mario Negri Irccs Institute for Pharmacological Research, is convinced of this, who in an interview with Alleati per la Salute (www.alleatiperlasalute.it), the medical-scientific information portal created by Novartis, takes stock of present and future of this innovative tool.

The tools of digital medicine, says Santoro, “unlike those of digital health, are fully inserted in a healthcare context, through applications of different types. Some of them are equipped with sensors useful for monitoring remote pathologies, which are used at home directly by the patient.In addition, devices have been created for digital drug support, i.e. to support drug therapy, which aim to promote therapeutic adherence.Basic tools belong to this area, such as applications that remind the time of taking the therapies, together with extremely more sophisticated technologies, such as the so-called smart pills, which allow a controlled and diluted release of the drugs over time.Others still allow to identify episodes of atrial fibrillation or epilepsy, such as clocks and FDA-certified smart bracelets”.

Alongside many positive factors, however, “there are also critical points – explains the expert – which concern, among other things, the difficulties on the part of those who develop these tools in submitting them to scientific validation, or even the unawareness on the part them of the need to do so. This element makes it very complex to provide the necessary evidence relating to the safety and efficacy of the devices and slows down their inclusion in treatment pathways, both at the prescription and reimbursement levels”.

“Another problem – adds Santoro – concerns the lack of regulation for the instruments, above all for those much more advanced from a technological point of view”. In this regard, the researcher recalls that “a new regulation on medical devices came into force in May 2022, which requires more evidence of safety and clinical efficacy from clinical trials to be provided”.

“This is an important step forward – underlines Santoro – but more needs to be done, especially in Italy, as regards the legislation that makes it simple to prescribe and reimburse those solutions, which can be included in the Pdta (Diagnostic Therapeutic Assistance Pathways) for where the evidence of safety and efficacy is sufficiently robust. Finally, there is the problem of digital skills in healthcare. Training doctors and patients in digital medicine would help create or enhance them”.

The complete article is available at: https://www.alleatiperlasalute.it/alla-scoperta-di/presente-e-futuro-della-medicina-digitale.