Digital Therapies: when the Medicine is Software


Teresa Minero for ICF – Rivista dell’Industria Chimica e Farmaceutica – May 2020

The Digital Therapeutics Alliance (DTA) defines Digital Therapies (or DTx) as follows:

“They offer scientifically supported, therapeutic interventions to patients, who are then monitored by high-quality software programs to prevent, manage or treat a broad spectrum of behavioural, physical and mental conditions.”


DTx are already part of current procedure and are applied in the treatment of an increasing number of diseases: Diabetes, respiratory problems, high blood pressure and more. Some DTx have been already approved by regulators (FDA, MHRA).

The main function of a DTx is to integrate into, or even substitute traditional therapy (Medicine). The peculiarity is that they can be clinically validated by rigorous clinical trials), be approved by regulators, be subject to a Health Technology Assessment (HTA) and therefore be subsequently prescriptible.

The active ingredient, so to say, is software that implements algorithms of varying complexity, integrating them with equipment / sensors (wearable, biometric or otherwise) and allowing information to be easily accessible on a smartphone, tablet or pc. Information then available to the patient and treating physician, with full regard to one’s privacy and security.

Such methods help to alter a patient’s lifestyle, improving the state of their condition. This would typically arise through use of external devices (meters of various clinical parameters, scales, surrounding air quality), intelligent and personalized processing of collected data, including indications for the patient and treating medical expert to follow.

An indication from LifeBee Experience

The Life Sciences world has a well-established culture of binding regulation and standards which serve as a benchmark for correct software lifecycle management when it has (directly or indirectly) a possible influence on the quality of the medicine or medical device. All systems must be validated and qualified according to strict procedures, and are now established in the industry and constantly inspected by regulators.

Valuable support for industry operators originates from ISPE GAMP guidelines® which provide the industry and its suppliers with methodologies and practice for the design, documentation, testing and maintenance of all such related software with a potential impact on the quality of medicines or medical devices, and ultimately on patient health.

DTx is software that in essence acts as medicine in curing humanity, with a substantial impact on a person’s health.

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