Europe is realising the benefits of telemedicine in coping with a surge in demand for remote professional communication. Raposo (2016) critiques this strategy’s strengths and weaknesses, highlighting that its growth potential is an expanding niche for governments and private entities to take advantage of.

Anyone betting on telemedicine would be pretty happy, considering that in 2018, the global market estimated 2013 for telemedicine was €16.3 billion and was projected to reach €37 billion by 2020 (Source: EU Commission Market Study on Telemedicine, 2018). Bloomberg estimated that now the market size is around $40 billion and will increase to a staggering $225 billion by 2030 at a compound annual growth rate of 18 per cent.

The EU Commission endorsed telemedicine since cross-border healthcare among member states must be regulated to ensure proper safe trade of professional services and cooperation among public health organisations. The application of procedures, services, product use and professional techniques benefit from the novelty of handheld communication devices and technologies.

Europe now intends to leverage the increased access to professional services provided to remote users. Telemedicine may require robotics being manipulated by a superspecialist in another EU country, interpreting medical images in real time by a colleague in Germany, or the ambulance nurse videoconferencing with the lead emergency physician waiting for you at the acute care hospital.

Telemedicine is, in fact, defined as “the provision of healthcare services, through the use of ICT, in situations where the health professional and the patient (or two health professionals) are not in the same location. It involves secure transmission of medical data and information, through text, sound, images or other forms needed for the prevention, diagnosis, treatment and follow-up of patients.”

The Treaty on the Function of the European Union (TFEU) incorporated telemedicine services in Articles 56 and 57, obliging unrestricted intra-European provision of services. This right also includes several EU regulations and directives since telemedicine is both a professional activity and a data-sharing encounter.

To mention a few of the relevant agreements in place by Raposo, one must contend with the Data Protection Regulation, the Directive on Services of the Information Society, the Electronic Commerce Directive, and the e-Privacy Directive. Professional health services are regulated by the Cross-Border Directive, providing a framework for medical care among public health authorities.

Ethical and legal repercussions on health professional practice

National and EU laws allow for prescribing medicines by any EU doctor to patients in the EU. Domestic pharmacists would have to look up a professional’s name in a register, understand the language the prescription is written in, and contact the doctor if needed. It is hardly user-friendly, and pharmacists are unlikely to dispense medicines using a prescription they are uneasy with. For domestic practitioners providing a prescription via telemedicine services to a patient in Malta, the Cross-Border Directive does not apply.

The Cross-Border Directive also tasks member states with ensuring that patients have access to their health records in an electronic medium; knowledge of the professional standards in place and their regulatory oversight; the competence and licensing standards of their telemedicine provider; and the ability to seek redress if harm occurs from treatment given according to the laws of the member state hosting the teleprovider. Professionals also benefit from protection since insurance providers must cater for compensation services resulting from injuries caused via telemedicine services.

The sharing of data is the responsibility of the data controller mostly.

There exists the risk of creating new inequalities for those lacking access to IT if health services become more telemedicine-dependent

A chain of information suppliers and receivers interact, including IT personnel, medical professionals, subcontractors and cloud storage providers. Patients must consent to the possibility of a data-protection breach by the data provider before sending data, given the risk of hacking.

Aside from the encouraging business forecast, telemedicine is here to stay after COVID-19 made the global health market dependent on it. Besides industrialised nations, telemedicine brings services to developing countries where travel is costly, time-consuming and occasionally dangerous.

Professional expertise can be provided at a distance for run-of-the-mill chronic conditions such as high blood pressure and diabetes.

The downside is the costly infrastructure to maintain and the ethical-legal implications that lawyers, insurers, employers and professionals must contend with.

There also exists the risk of creating new inequalities for those lacking access to IT if health services become more telemedicine-dependent.

The other threat is that member states may be tempted to employ further telemedicine services as a cost-cutting exercise at the expense of patients who wish more direct physical access to healthcare professionals. This runs the risk of institutions looking at the cost-benefit aspect of healthcare rather than the individual premise of well-being, in violation of Articles 1 and 2 of the Oviedo Convention.

On the other hand, doctors also fear that lack of physical contact can erode the trust between them and their patients.  This is especially relevant for primary-care consultations that rely on frequent contact. This may lead to problematic consent, which should be obtained before the commencement of the consultation.

As with other patient data-gathering situations, one may encounter disturbing information incidentally. Professionals should be aware of the possibility of encountering problems not part of the intended consultation process, such as witnessing abuse or acknowledging harmful thoughts expressed by patients. This may include a duty of care to such patients by ensuring that safeguards are in place for proper reporting and intervention promptly.

Another challenge is the obligation to provide patients with their data digitally. One asks who is responsible for such an endeavour? Should primary-care providers working solo also have to keep a database of information that can be forwarded at a moment’s notice? If so, what should the contractual agreement state when sharing such knowledge?

Does having access to such information increase the burden of responsibility on doctors and healthcare providers? How would health systems at different levels of telemedicine advancement cooperate? Would this lead to a telemedicine arms race of standards?

Do we have enough trained individuals to cater for the regulation before implementing it, or should we take a step back and consider whether it is worth investing in such a heterogenous framework that changes regularly?

For larger EU countries, these questions can be managed among experts in the field in liaison with international bodies that regulate telemedicine ethics, such as TeleSCope. However, with its culture and political climate, micro-states like Malta tend to lack the resources to enforce such regulations regarding data-sharing. A single well-equipped authority would likely have to overlook this endeavour and prevent problems before they occur.

Ian Baldacchino is a general practitioner and second-year candidate for a master’s in bioethics. He is also a member of the Medical Council Malta.