In the heterogenous category of digital healthcare technologies, software with a medical purpose - i.e. therapy, diagnosis, prevention of a disease or monitoring of adherence to treatment - is expected have a strong impact. Indeed, it conforms to models of development and market access which are typical of information technology and unusual for healthcare. Avoiding any regulatory uncertainty is crucial for companies and competent authorities. In the European Union (EU), software with a medical purpose qualifies as a medical device, for which a strong regulatory framework is already in place. However, for patient-managed digital medical devices (pDMDs), i.e. software with a medical purpose intended to be used directly by patients, some open issues are still on the ground. These issues arise both at the EU level, related to risk-based classification and clinical evaluation, and the national level, related to prescription and reimbursement policies. The aim of this article is to analyse the classification and regulation of pDMDs in the EU, exploring the need of additional definitions, legislation or guidance.

Patient-managed digital medical devices: Do we need further regulation? / P. Minghetti, U.M. Musazzi, S. Manellari, V. Pagella, P. Rocco. - In: INFORMATICS IN MEDICINE UNLOCKED. - ISSN 2352-9148. - 47:(2024 Apr), pp. 101506.1-101506.4. [10.1016/j.imu.2024.101506]

Patient-managed digital medical devices: Do we need further regulation?

P. Minghetti
Primo
;
U.M. Musazzi
Secondo
;
S. Manellari;V. Pagella
Penultimo
;
P. Rocco
Ultimo
2024

Abstract

In the heterogenous category of digital healthcare technologies, software with a medical purpose - i.e. therapy, diagnosis, prevention of a disease or monitoring of adherence to treatment - is expected have a strong impact. Indeed, it conforms to models of development and market access which are typical of information technology and unusual for healthcare. Avoiding any regulatory uncertainty is crucial for companies and competent authorities. In the European Union (EU), software with a medical purpose qualifies as a medical device, for which a strong regulatory framework is already in place. However, for patient-managed digital medical devices (pDMDs), i.e. software with a medical purpose intended to be used directly by patients, some open issues are still on the ground. These issues arise both at the EU level, related to risk-based classification and clinical evaluation, and the national level, related to prescription and reimbursement policies. The aim of this article is to analyse the classification and regulation of pDMDs in the EU, exploring the need of additional definitions, legislation or guidance.
Digital therapeutics; Medical device software (MDSW); Patient-managed digital medical device (pDMD); Software as medical device (SaMD)
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
apr-2024
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/1047153
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