According to the Authority, initiative medicine is not strictly necessary for prevention and treatment and the ESF cannot be used for this.
In the provisions that the Guarantor has issued against three Friuli ASLs for having applied initiative medicine in a way that does not comply with the regulation (here you can read a report) there are two principles that arouse strong perplexities.
Initiative medicine is not strictly necessary for treatment and prevention
The Guarantor has decided, motu proprio, that self-initiated medicine is not part of ordinary treatment and prevention activities. I quote what was stated in point 3.2 of pprovision relating to the Western Friuli University Company:
“With specific reference to the purposes of treatment and prevention, it should be noted that the Guarantor has already highlighted that such treatments must be considered additional and independent of those strictly necessary for ordinary treatment and prevention activities (Article 9, paragraph 2, letter h ) of the Regulation), and therefore can only be carried out on the basis of the specific informed consent of the interested party (Article 9, paragraph 2, letter a) of the Regulation) (see ex multis, opinion on the draft law of the Autonomous Province of Trento which contains specific provisions on initiative medicine, of 8 May 2020, web doc. n. 9344635)”.
But that’s not enough, the Guarantor states that
The Electronic Health Record cannot be used for proactive medicine
This statement is contained in point 3.3 in which he declares:
“It should also be noted that through the electronic health record (FSE) the purposes set out in the specific discipline of the sector can be pursued and in particular those of: a) diagnosis, treatment and rehabilitation; a-bis) prevention; a-ter) international prophylaxis; b) study and scientific research in the medical, biomedical and epidemiological fields; c) health planning, verification of the quality of care and assessment of health care (art. 12, 18 October 2012, n. 179, converted with amendments into law 17 December 2012, n. 221, and dpcm 29 September 2015, n. 178).
Among the aims that can be pursued through the ESF, therefore, the one relating to predictive or initiative medicine does not appear. The legislator, in fact, even in the recent interventions carried out on the matter, has not extended this purpose among those that can be pursued through the ESF. The data accessible through the ESF, deprived of direct identification elements, may instead be processed by the Ministry of Health, also through interconnection with other data sources, for the purposes and with the methods that will be established by decree of the Minister of Health, which must be adopted with the opinion of the Guarantor, in compliance with the provisions of the Regulation, the Code, the Digital Administration Code and the guidelines of the Agency for Digital Italy on interoperability (Article 2-sexies, paragraph 1-bis) (see also opinions given by the Guarantor on 22 August 2022, n. 294 and 295 web doc. n. 9802752 and 9802729)”.
An interpretation that leaves us perplexed
The Guarantor, in this provision, provides an interpretation of the initiative medicine establishing that this is further and independent of the ordinary treatment and prevention activities and then affirming that it does not fall within the aims of the FSE, in which prevention, diagnosis and the cure.
I report below some definitions of health care or initiative medicine.
Agenas – DM 77: “The initiative healthcare it is a care model for the management of chronic diseases based on proactive assistance to the individual from the stages of prevention and health education up to the early and full-blown stages of the morbid condition.”
ARS Toscana: “Per proactive healthcare means a model of care chronic disease management that does not wait for the citizen in the hospital (waiting healthcare), but “goes to meet” him before the pathologies arise or worsen, thus guaranteeing the patient adequate and differentiated interventions in relation to the level of risk, also focusing on prevention and oneducation”. Still: “The proactive healthcare aim at both prevention than to the improvement of management from the chronic diseases at each of their stages and therefore concerns all levels of the health system, with positive effects expected for both the salute of the citizens who for the sustainability same as the system”.
In summary: healthcare or initiative medicine is a care model that concerns the prevention and management (treatment) of chronic diseases.
It is certainly true that it is not explicitly mentioned among the purposes of the ESF but it is equally true, in my opinion, that it falls within the headings of prevention, diagnosis and treatment. This is, in my view, a conceptual error that has important health implications.
I think it is urgent and necessary that the Ministry of Health, the Regions and the orders of doctors express themselves on this issue by opening a discussion with the Guarantor who, in my opinion, has neither the task nor the competence to decide what is the medicine of initiative.