Blog: From e-health to digital Health: Telemedicine, Electronic Healthcare File, Artificial Intelligence – Lexology
In the last five decades we have been assisting on the digitalization of society and consequently of the healthcare sector; we have been using terms such as eHealth, medical informatics, health informatics, telemedicine, telehealth and mHealth, depending on the available technologies and accessibility of the baseline infrastructure.
These terms have been used to describe the application of information and communication technologies (ICTs) to areas of health, health care and wellbeing.
More recently, with the introduction of Artificial Intelligence, we have been assisting with the transition from eHealth to Digital Health that is flexible enough to foster diversity of purposes, technologies and other specificities.
The World Health Organization stated that: “Moving from eHealth to Digital Health puts more emphasis on digital consumers, with a wider range of smart-devices and connected equipment being used, together with other innovative and evolving concepts as that of Internet of things (IoTs) and the more widespread use of artificial intelligence (AI), big data and analytics. Digital Health is changing the way health systems are run and health care is delivered”.
Digital Health also includes the following aspects: Telemedicine, Electronic Healthcare File and Artificial Intelligence.
This article aims to give a succinct overview of the current rules that cover such aspects in in Italy by looking at local regulations and recent developments at a European and international level.
On the 3rd of March 2015, Italy adopted a 6-year plan for digital growth called “2014-2020 digital growth strategy“. It followed the “2019-2021 three-year plan“. Both plans tackle digital transformation in the public sector, including healthcare.
In the transformation of healthcare into e-health, they play a decisive role in the introduction of telemedicine, the electronic file and artificial intelligence.
Telemedicine is not expressly regulated by Italian law. However, on 17 March 2014, the Italian Ministry of Health adopted guidelines (hereinafter the “Guidelines”) which contain several principles and rules applicable to Telemedicine.
Under the Guidelines, Telemedicine is defined as a way to provide healthcare services through the use of innovative technologies, in particular Information and Communication Technologies (ICT), in situations where the healthcare professional and the patient, or two or more healthcare professionals, are not in the same place.
Pursuant to the Guidelines, Telemedicine for the purposes of secondary prevention, diagnosis, treatment, rehabilitation and monitoring, can encompass the following services:
During the tele-examination, it is possible to prescribe medicinal products and health treatments. For this purpose, it is necessary that the doctor can see and interact with the patient at a distance (through a telecommunications infrastructure). Such examination can take place in real time or it can be deferred.
- Tele-health: this concerns the primary healthcare and “covers the systems and services that connect patients, especially the chronic ones, with the doctors to assist in the diagnosis, monitoring, management and accountability of the same.”
Tele-monitoring: this “covers remote assistance, we mean a social assistance system to take care of elderly or fragile at home, through the management of alarms, activation of emergency services, calls to “support” by a service centre. Remote assistance has a predominantly social content […] in order to guarantee the continuity of the assistance”.
According to Section 3 of the Guidelines, Telemedicine services should be organized as follow:
- the Users – individuals using a telemedicine service, and for this purpose sending health information and/or receiving relevant results). User can be:
the patient / caregiver (tele-examination; tele-consultation);
the doctor in the absence of the patient (tele-consultation);
the doctor or another health care professional (tele-examination, tele-cooperation).
the Provider [OB1]– providers of healthcare services through a telecommunications network (or infrastructure). A Provider may be:
Entities belonging to the Italian National Healthcare System (NHS), authorized or accredited, either public or private;
Healthcare professionals belonging to the NHS (i.e. general practitioners, paediatricians, medical specialists).
The Provider [OB2]receives health information from the User and returns the results of the service.
- the Service Centre – has the responsibility for the management and maintenance of the information system, including transmission and storage of relevant information.
Since Telemedicine is treated as a way to perform “traditional” healthcare services by overcoming “common physical barriers”, Providers should hold all authorizations normally required for the performance of health and socio-health activities in a traditional manner (see Italian Legislative Decree n. 502/92) and all additional authorisations which may be required in relation to the IT tools used to perform the relevant healthcare services.
In addition, if a Provider intends to offer Telemedicine services at cost of the NHS, it should also obtain a regional accreditation and (sometimes) conclude contractual arrangements with the concerned Italian Regions  where the telemedicine service will be provided.
Given the possible developments and the importance that Telemedicine might have in the future, in March 2019 a National Study Group on the “economic assessment of telemedicine service” was created. Its purpose is to create a model, compatible with the Italian NHS, to evaluate and programme services provided in Telemedicine and to identify new pricing systems.
ELECTRONIC HEALTHCARE FILE
Electronic Healthcare File (EHF) is essentially “the electronic management of clinical practices”, intended to facilitate the sharing of documents through platforms. EHF was first introduced by Article 12 of Legislative Decree n. 179/2012.
The main aims of the EHF are: a) to facilitate patient healthcare; b) to offer a service that facilitates the integration of the various professional skills in the healthcare sector; and c) to provide consistent clinical information about a patient.
Italian law regulates the relevant data sharing as follows: (i) patient identification should be ensured by associating a patient social security number to a patient “unique code” (see Article 1, letter m) of Legislative Decree n. 178/2015), whilst (ii) interoperability of electronic documents within the NHS should be ensured by the adoption of regional platforms which are able to safely dialog with INI, thanks to the adoption of common methods and characteristics.
Artificial Intelligence (AI) systems are “software (and possibly also hardware) systems designed by humans that, given a complex goal, act in the physical or digital dimension by perceiving their environment through data acquisition, interpreting the collected structured or unstructured data, reasoning on the knowledge, or processing the information, derived from this data and deciding the best action(s) to take to achieve the given goal. [..] AI includes several approaches and techniques, such as machine learning (of which deep learning and reinforcement learning are specific examples), machine reasoning (which includes planning, scheduling, knowledge representation and reasoning, search, and optimization), and robotics (which includes control, perception, sensors and actuators, as well as the integration of all other techniques into cyber-physical systems)”
Currently, the application of AI to the healthcare sector is not expressly regulated under Italian law. However, given the increasing importance of AI, the World Health Organization, European Commission and National Governments have set up ad hoc committees for the purpose of studying the matter and to drafting initial guidelines.
On the 4th of February 2019, the US Food and Drug Administration (“FDA“) published a discussion paper regarding the application of adaptive artificial intelligence (“AI“) and machine learning (“ML”) in software classified as a medical device (“SaMD”). The FDA framework proposal suggests that when AI has the potential to adapt and optimize device performance in real-time to continuously improve health care for patients (so-called “adaptive software”), it should be subject to a “predetermined change control plan” in premarket submissions. This plan should include the types of anticipated modifications of the SaMD” and the associated methodology being used to implement those changes in a controlled manner while managing the risks to patients (referred to as the “Algorithm Change Protocol”).
Also in relation to AI and medical devices, the European Parliament said in its resolution of the 12 February 2019 that “when AI is being used in implanted medical devices, the bearer should have the right to inspect and modify the source code used in the device […] the existing system for the approval of medical devices may not be adequate for AI technologies; calls on the Commission to closely monitor progress on these technologies and to propose changes to the regulatory framework if necessary in order to establish the framework for determining the respective liability of the user (doctor/professional), the manufacturer of the technological solution, and the healthcare facility offering the treatment”.
In line with this, on the 8th of April 2019, the European Commission’s High-level Expert Group on Artificial Intelligence (AI HLEG), published the “Ethics Guidelines for Trustworthy AI”(hereinafter “Ethics Guidelines”).
The Ethics Guidelines aim to promote a trustworthy AI and is divided into four macro-areas: I) Trustworthy AI; II) foundations of Trustworthy AI; III) Realisation of Trustworthy AI; and IV) Assessment of Trustworthy AI.
Trustworthy AI is defined as AI which is compliant with the following principles:
lawfulness (i.e. compliant with all applicable laws and regulations);
ethical (i.e. adherent to ethical principles and values; and
robust (i.e. reliable from a technical and social perspective).
The Ethics Guidelines describes these principles as follows:
Lawfulness should not only be interpreted as “what cannot be done”, but also in the sense of “what should be done or may be done”.
AI should comply with: “all legal rights and obligations that apply to the processes and activities involved in developing, deploying and using AI systems [..].”
These legal sources should include, but are not limited to: “EU primary law (the Treaties of the European Union and its Charter of Fundamental Rights), EU secondary law (such as the General Data Protection Regulation, the Product Liability Directive, the Regulation on the Free Flow of Non-Personal Data, anti-discrimination Directives, consumer law and Safety and Health at Work Directives), the UN Human Rights treaties and the Council of Europe conventions (such as the European Convention on Human Rights), and numerous EU Member State laws.”
Besides horizontally applicable rules, various domain-specific rules exist that apply to particular AI applications, such as for instance “the Medical Device Regulation in the healthcare sector”.
AI systems should also comply with the ethical codes of each sector where AI is implemented and adhere to ethical principles based on fundamental rights, such as 1) respect for human autonomy; 2) prevention of harm; 3) fairness; and 4) explicability. According to the Ethics Guidelines, only a “human-centric approach” can ensure the respect of the above-mentioned principles.
AI “…should perform in a safe, secure and reliable manner [..] both from a technical perspective (ensuring the system’s technical robustness as appropriate in a given context, such as the application domain or life cycle phase), and from a social perspective (in due consideration of the context and environment in which the system operates)”.
The Ethics Guidelines provides a list of concrete requirements that should be met in order to comply with the above-mentioned principles and to achieve a trustworthy AI, these are: 1) human agency and oversight; 2) technical robustness and safety; 3) privacy and data governance; 4) transparency; 5) diversity, non-discrimination and fairness; 6) environmental and societal well-being; and 7) accountability”.
The applications of AI in the health sector are manifold.
For the European Commission “Trustworthy AI technologies can be used – and are already being used – to render treatment smarter and more targeted, and to help preventing life-threatening diseases. Doctors and medical professionals can potentially perform a more accurate and detailed analysis of a patient’s complex health data, even before people get sick, and provide tailored preventive treatment. In the context of Europe’s ageing population, AI technologies and robotics can be valuable tools to assist caregivers, support elderly care, and monitor patients’ conditions on a real time basis, thus saving lives.
Trustworthy AI can also assist on a broader scale. For example, it can examine and identify general trends in the healthcare and treatment sector, leading to earlier detection of diseases, more efficient development of medicines, more targeted treatments and ultimately more lives saved”.
Digital Health is likely to introduce new business models, which are expected to increase the efficiency of healthcare services, and reduce the time for their performance.
These efficiencies might free-up additional resources that can be used to improve the accessibility, quality and affordability of healthcare services, with the aim of guaranteeing a better life for people; in particular, the ones affected by chronic diseases.
However, Digital Health, and in particular AI, should be regarded as the “longa manus” of human agents, with the purpose of helping them but not replacing them. Coherently with that view, new technologies should be human centred and adequately overseen.
Because Digital Health is in continuous evolution, it is particularly important for all stakeholders to adequately monitor, know and understand the applicable rules as well as relevant business opportunities.