Home care digital healthcare is crucial for private facilities seeking to operate within the national health service

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The Italian Competition Law stipulates that in contracting private healthcare providers to operate within the national health service, the health authority must take into account the effective, continuous and timely supply of the electronic health records (FSE). From here to the enhancement of digital health services the leap is short.

The debate on the digitisation of the Italian National Health Service (SSN) and the development of home care - processes that are strongly connected and both promoted by Mission 6 of the PNRR - seems to be centred, again, around the changes that will occur in the services provided by the public sector.

Let us start from the beginning.

Home care in Italy

Home care has been included among the deliverable healthcare services since Law 833/1978, establishing the National Health Service (Art. 14 and Art. 25). In practice, however, the SSN has experienced a mostly 'hospital-centric' development.

The first important step was taken with the Prime Ministerial Decree of 12 January 2017 approving the Essential Levels of Care (LEA), which in Article 22 regulates in detail Basic Level Home Care and Integrated Home Assistance (ADI) at Levels I, II, and III, thus paving the way for the Regions to finance this type of service and for citizens to request it.

With Budget Law 2021 (Law No. 178 of 30 December 2020) - driven by territorial needs made evident by the pandemic - the Legislator made important changes to the authorisation regime (Art. 8-ter, para. II, Leg. Decree No. 502 of 1992) as well as to the accreditation regime (Art. 8-quater of Legislative Decree No. 502 of 1992). These provide, for the first time, that entities intending to provide home care must obtain specific authorisation and specific accreditation (the requirements, however, must be established at regional level).

The National Recovery and Resilience Plan (PNRR) as a turning point

But the real turning point occurred during the summer of 2022.

In June, in implementation of Mission 6 component 1 of the PNRR, the Ministerial Decree of 23 May 2022 was published, titled ‘Regulation defining models and standards for the development of territorial care in the National Health Service’. Within it, for the first time, a new territorial healthcare has been designed and organised around Community Homes, Community Hospitals and Territorial Operating Centres.

The entire system revolves around the idea of the 'home as a place of care' by enhancing telemedicine and digital health in general, as well as proper data collection. These would allow the development of Population Medicine (promoting models for the stratification and identification of health needs) as well as Initiative Medicine (a care model for the management of chronic diseases based on proactive assistance to the individual from the prevention and health education stages right up to the early and overt stages of morbid conditions).

In August, Law No. 118 of 5 August 2022 - Annual Market and Competition Law 2021, the so-called 'Competition Law', was passed to promote the development of competition and to remove regulatory barriers to market opening (also an expression of a PNRR Mission).

This particular opening is specifically directed towards private healthcare.

Opening up to private healthcare

In fact, the new Law significantly modifies through Art. 15 the aforementioned Leg. Decree No. 502/1992, not only on the subject of healthcare accreditation but in particular on the choice of contractors in contractual agreements between accredited healthcare entities and health authorities.

With reference to accreditation, the new wording of Art. 8-quater, para. 7 of Leg. Decree No. 502/1992 introduces changes that make it easier to obtain accreditation.

The previous version of the institute envisaged - for new healthcare facilities or for the establishment of new activities in pre-existing facilities - the possible granting of 'provisional' accreditation (subject to compulsory and positive verification of the volume of activity performed and the quality of its result). Today, on the contrary, new providers can directly obtain a definitive accreditation, by indicating 'only' the activity already performed and the results previously obtained, even in a private regime. Obviously, these remain subject to the objectives and results of the control and supervision activities in terms of quality, safety and adequacy of the healthcare services by the Public Administration.

Therefore, for those entities that are deciding to implement and develop telemedicine and digital health services (and after Covid-19, many private facilities are moving in this direction), it will be much easier in the future to apply for accreditation by presenting the results of what has been achieved through such new technology tools.

Changes regarding contractual agreements

On the subject of contractual agreements, the changes are even more impactful. Article 8-quinquies of Leg. Decree 502/1992 introduces paragraph 1-bis, which reads as follows:

The private entities referred to in paragraph 1 are identified, for the purpose of entering into contractual agreements, by means of transparent, fair and non-discriminatory procedures, following publication by the regions of a notice containing objective selection criteria, which give priority to the quality of the specific healthcare services to be provided.

The selection of these entities must be carried out periodically, taking into account the regional health planning and on the basis of checks on any rationalisation needs of the network under contract and, for entities already holding contractual agreements, on the activity carried out;

In essence: the choice of private healthcare entities providing services at public charge must be made through a public and competitive procedure.

Therefore, contracts with private entities (commonly referred to as 'conventions') will have to move away from the current 'historical' approach - which in essence continued to grant them to the same providers as always - and towards a system in which whoever is able to offer the best services in terms of quality is awarded the contract.

The importance of digitisation for private facilities

In essence, the health authority must, alongside the 'minimum' structural requirements for access to the selection, identify a series of qualitative and technical elements to be given greater prominence for selection purposes and to which, if necessary, specific scores can be allocated in favour of health facilities that meet them.

And it is precisely in this selection phase that the digitisation of the private structure can only gain in importance.

This direction is demonstrated by the Competition Law itself, which, in Art. 15, establishes that for the selection procedure of the private entity, the health authority "...shall also take into account the actual continuous and timely supply of the electronic health record (FSE) pursuant to Article 12 of Decree-Law No. 179 of 18 October 2012, converted, with amendments, by Law No. 221 of 17 December 2012..."

In other words, it is established that the main criterion for the selection of the private entity is its ability to supply the FSE in a continuous and timely manner. It is only a short step from here to the enhancement of digital health services.

It is clear that if the Electronic Health Record (i.e. one of the pillars of the development of digital health in Italy) plays a leading role in future selections of private healthcare providers, it is highly likely (for this writer at least) that telemedicine or digital health services will be given a preferential path in competition procedures, if only for their functional 'affinity' with the FSE.

Conclusions

We are therefore on the threshold of a turning point.

The entire home care system in Italy needs to be established and developed, the private sector that will work with the public sector will no longer automatically be the same as always as more new private sector providers will be allowed to enter, also depending on their ability to implement telemedicine and private healthcare.