Digital Health Update and an Italian Experience of Telemonitoring

Giuseppe Germano, MD FESC

Sapienza Università di Roma

A brief history of the Digital Health at the European Society of Cardiology can, in the short term, start from the “e-Health: a position statement of the European Society of Cardiology” from 2016. It stated that Digital Health is the use of information and communication technologies (ICTs) in the support of health and health-related activity and it subdivided it into several domains:

1. Telemedicine and telecare (including disease management services, remote patient monitoring, teleconsultations, and homecare)
2. Clinical information systems (electronic medical records, decision support and monitoring of clinical and institutional practice)
3. Integrated regional and national information networks and associated e-referrals and e-prescribing
4. Disease registries and other non-clinical systems used for education, public health, patient/disease-related behaviour, and healthcare management
5. ‘Mobile’ health (m-health) including mobile applications (‘Apps’): medical and public health practice supported by mobile technologies delivering health information, screening patients, monitoring physiological signs, providing direct care and patient education (sometimes considered part of telemedicine, but increasingly less medicalised)
6. ‘Personalised’ health (p-health): wearable or implantable micro- and nano-technologies with sensors and/or therapy delivery devices to help facilitate health and social care decision making and delivery (including fall detectors, implantable insulin pumps, defibrillator vests, etc.).
7. ‘Big Data’—large-scale integration and analysis of heterogenous data sources, usually of high volume (amount of data), velocity (speed of data in and out), and variety (range of data types and source), ideally linked at the individual person level to provide a more holistic view of a patient/individual and shed light on social and environmental factors that may influence health.

The technology should improve care particularly for those living with chronic conditions, yield familiar ICT and find it supporting modern healthcare delivery, facilitating more personalised and person-centred care at the right time and in the right place. In theory, should bring better inter-professional co-operation, information sharing, decision support, and flexibility to the healthcare system.

The European Union has an e-health action plan for 2012–2020, which states that the promise of ICT to increase efficiency, improve quality of life, and unlock innovation in health markets remains largely unfulfilled. Initiatives such as large-scale pilot projects (e.g. European patients smart open services), the 2011 Directive on the Application of Patients’ Rights in Cross Border Healthcare, and the establishment of an e-health network have made some difference but the Action Plan identified several barriers to widespread adoption of e-health, including:

1. Lack of awareness of, and confidence in, e-health solutions
2. Lack of inter-operability
3. Limited large-scale evidence of the cost-effectiveness
4. Lack of legal clarity for health and wellbeing mobile applications and the lack of transparency regarding the utilisation of data collected, including data that crosses international boundaries
5. Inadequate, or fragmented, legal frameworks
6. Lack of reimbursement
7. Regional differences in accessing ICT services, with limited access in deprived areas

The European Society of Cardiology is currently active in key topics relating to digital health in cardiovascular health and care: from electronic medical records to clinical support using artificial intelligence, from e-prescribing to mobile health, and from cybersecurity to data protection, prof. Cowie explains “Digital Health has a much greater presence at ESC Congress 2019 than in previous years, with a larger Digital Health Area and a fuller scientific program to reflect the growing role of new technologies and the ESC’s  involvement in the key topics”.

Prof.  Bax, president of the ESC,  says “e-health offers physicians positive opportunities but the speed of change is a challenge, occasionally it can be quite disruptive for physicians and patients because we suddenly have access to such a degree of detailed information that we need to reconsider our first assessment or even launch new investigations: however these cutting-edge technologies are heading the right way by allowing to perceive things like never before”.

First of all, about the digital health solutions in clinical practice, the electronic medical records, often perceived as detrimental to the patient-healthcare professional relationship, if numerous boxes need to be completed on screen during a consultation, led to the development of less unwieldly digital solutions to improve data flow, with greater standardisation. Regarding to remote monitoring by e-health and m-health in the management of heart failure, IN TIME trial showed that these technologies have evolved a standard feature for almost all patients with pacemakers or defibrillators, have a beneficial impact on mortality, improve workflow, reduce resource utilisation and costs, and do not have a negative impact on Qol.

In addition algorithms supplement and partially replace traditional diagnostic an treatment pathways, and support patient values, i.e. better and longer life.

Relating the personal digital health, the latest on wearables, smart textiles and Apps will be covered. A symposium discussed Apps developed as part of the Horizon 2020-funded consortium, CATCH ME (Characterising Afib by Translating its Causes into Health Modifier in the Elderly): an App (AF Manager) designed to be used by health care professionals and an App (my AF) by patients with atrial fibrillation.

The results were presented about a health service in the hands of every person by Babilon’s GP At Hand that offer 35 000 NHS patients video calls and access to its triage chatbot for advice on whether to see a doctor. Various symposia, poster sessions and interactive activities during ESC Congress 2019 have made these terms: artificial intelligence, big data and machine learning as component of cardiologists’ vocabulary.

There are concerns that artificial intelligence and machine learning may replace human intelligence with regards to clinical reasoning: the datasets generated are much larger than we have seen before and bigger than individual clinicians may develop over a lifetime of experience, some caution is warranted.

“Navigating this dynamic fast-moving area is difficult—we don’t want to be drowned in a tsunami of data, but we should take what’s valuable from these approaches to maximise benefit for patients and healthcare systems.” Prof. Cowie said.

Electronic monitoring has already been very effective in managing diabetes and other conditions. In Scotland, 285,000 diabetic patients are involved in the national programme ‘My Diabetes My Way’ where they record their own data such as blood glucose levels and blood pressure from the comfort of home.

At the end of this partial review, it is mandatory to report a series of solutions to the perplexities still present in healthcare representatives:

1. Establish patient digital health education programs
2. Redesign contemporary workflow model
3. Establish European-wide digital health certification programs
4. Assure compliance to applicable digital health directives
5. Assure interoperability of digital health services
6. Encourage economical evaluation of digital health based care
7. Inform health insurance industry & policy makers
8. Stimulate digital health related knowledge & experience sharing

In addition I refer to an Italian experience in telemedicine that uses pharmacies that have an ubiquitous presence in the territory (they are 18023 with a ratio of 29.55 pharmacies per 100,000 inhabitants). 4590 (25.46% of pharmacies have adhered to the “Farmacia dei servizi” project, have made suitable structures available to carry out an electrocardiogram with trained personnel, apply a device for monitoring blood pressure and electrocardiogram for 24 hours or more.

Through a dedicated platform and with all the criteria for safeguarding privacy, they send the traces to cardiologists who, with the patient's anamnestic data and any diary filled with activity symptoms and therapy, can report in fixed structure as “call center” or even through laptop and smartphone, wherever they are, returning it to the platform with a certified signature, from here the journey back in a short time to the pharmacy.

Ensuring the privacy of the data sent, there are procedures that allow to notify the pharmacy of any pathologies that have emerged from the tracings sent. The pharmacies involved provide a series of data (from three different societies) sufficient to identify a trend: the exams were 69,404 in the first half of 2019, 44% more than the half of 2018 (38,866), the greatest increase was recorded for the monitoring of ECG for 24 hours (+31%), and ECG and blood pressure monitoring have the same but minor increase (+14%).

A final note is related to the increase in the membership of new pharmacies in the same period, by 5%. There are no reimbursements, the service is completely private and the prices fluctuate around the ticket (participation in health expenditure) of public assistance for the exams offered.