lexisnexisip.com

Covid puts the legal spotlight on telemedicine: do not check this box lightly

Ioanna Michalopoulou

Michalopoulou & Associates, Greece

imicha@lawgroup.gr

 

Vicky Tatsi

Michalopoulou & Associates, Greece

vtatsi@lawgroup.gr

 

Telemedicine towards an EU legal framework

According to the European Commission, telemedicine can be 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’. Telemedicine takes many forms with unique characteristics, such as telemonitoring, tele-education, teleintervention and teleconsultation (between doctor and patient or between two or more healthcare professionals in order to discuss a certain medical issue).

In reality, telehealth communication tools include video conferencing, email, mobile (smartphones) or app-enabled technology, as well as store-and-forward or asynchronous technologies that can securely transmit sensitive clinical data (images, sound, video) collected from patient’s wearable devices or by other sources in order to be clinically evaluated. We do not therefore talk just about a virtual meeting between a patient and her doctor, but about a proactive, hyper-personalised and data-driven evaluation of the patient’s condition that must be compliant with GDPR provisions. There are already many kinds of these connected (wearable) medical devices related to different health measurements such as the measuring blood sugar, tachycardia/bradycardia, blood pressure, ultrasound etc. Note that telemedicine should also comply with HIPAA laws, which aim to prevent private or secure medical documents from being leaked. However, it cannot be guaranteed that data transmissions from an app or the abovementioned wearable devices may be shared with third-party advertisers or others.

Telemedicine, as a type of healthcare service, is interpreted in the light of Articles 56 and 57 of the Treaty on the Functioning of the European Union (TFEU), so telemedicine services are subjected to the general principle of free movement of services. Also, telemedicine, according to the European legal framework, is considered, on the one hand as a health service and on the other, as an information service. This means that both regulatory frameworks apply at the same time. Mainly during the last few years, there are many legislative initiatives at the EU level which aim to turn telemedicine into a standard medical procedure, to which every European citizen may have access and be reimbursed according to the provisions of his or her national social security system. Also, we should not forget that the e-Commerce Directive (Directive 2000/31/EC) also applies. This is the legal framework for online services in the Internal Market. Its purpose is to remove obstacles to cross-border online services in the EU and to provide legal certainty to business and citizens, including telemedicine services. Last but not least, the Directive 2011/83/EU on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC and repealing Council Directive 85/577/EEC and Directive 97/7/EC is also applied in this case.

Patients can also provide their electronic (digital) consent (e-consent). It can improve routine medical care, replace paper-based consent forms, eliminate travel times and additional costs, and empower more patients to ‘e-visit’ a physician. Now, we can talk about remote consent that includes phone calls, emails, and e-consent. However, one of the major challenges is the need for an electronic signature. An electronic signature is an effective tool in digital health, which indicates that a patient agrees with a given procedure. Some EU countries have already set up a national strategy concerning telemedicine. However, it is clear that almost all of them lack specific legal provisions regulating telemedicine practices. In many cases, already existing laws cannot keep up with recent telemedicine innovations and as a result, governments have to make a complete or partial revision and modification of the current laws in order to promote telemedicine and give solutions to resulting problems. The lack of widely adopted EU and global standards and procedures hurts trust in the quality and reliability of telemedicine services.

The Greek legal framework

Extensive legislative initiatives on telemedicine have not yet been undertaken in Greece. There is only one main provision for telemedicine services in the Greek legislation. More specifically, Article 66 par. 16 of Law 3984/2011 ‘Regulation of issues of the Health and Welfare Services Inspection Body, E.Κ.Α.Β. and hospitals’ foresees that: ‘Telemedicine services are provided as long as there is the possibility and with the responsibility of the treating physician who deals with each case. The treating physician, for reasons of personal data protection, is responsible for requesting from the patient or if this is not possible from a first-degree relative, the signed approval for the use of Telemedicine services. If this is not possible, then the treating physician uses Telemedicine services at his discretion. The instructions of the Hospitals and Health Units that provide Telemedicine services are advisory and in no case mandatory.’

Furthermore, Article 33 of Law 4633/2019 about the Establishment of a National Public Health Organization, regulations on tobacco products, etc. foresees the following: ‘Article 33. Establishment of an Independent Department of Health Operations at E.K.A.B. and a Unified Business Coordination Center Ε.Κ.Α.Β. 1. is composed in E.K.A.B. Independent Department of Health Operations, which is directly subordinated to its President. The Department has the following responsibilities: […] eg the responsibility for the operation of the Telemedicine system.’

Concerns about liability

In comparison to traditional medical procedures, many people in different positions will be liable if something goes wrong during a telemedical meeting. If it does, it may even lead to liability claims against software producers or internet providers. Also, in the case of a defective medical device, the Product Liability Directive establishes the general principle that a producer is liable for damages caused by a defect in its product. In general, a product is defective when it does not provide the safety that a person is entitled to expect, taking all circumstances into account, including the presentation of the product, the use to which it reasonably could be expected to be put and the time at which the product was into circulation. However, telemedicine might sometimes make it easier to find out who made the mistake, since teleoperations, for example, may be taped and be kept on the patient.

In the case of telemonitoring, where medical devices are implanted to the patient for monitoring purposes, liability gets centre attention. These devices send electronic messages and signals about the patient’s health to the doctor. However, these devices may not always contain an alarm system for emergency situations and do not always include all-day assistance. Also, the wearable software devices might integrate sensitive data from the patient’s health record, and after the application of AI, the results may trigger a proactive call to the user-patient smartphone even before he or she realises that something is wrong. This sort of biometrics-driven remote patient monitoring might be handled by a non-physician member of the care team. In this case, it is obvious that there is liability concern even for non-physician members who get involved in this procedure. Finally, before the beginning of any telemedicine procedure, patients must be accurately informed in written and oral form and in a way that they can understand, about the use of the device and the categories of information that are collected, or even the doctor’s limited availability in certain cases.

Barriers to accessing telemedicine – social security and private insurance

Generally, reimbursement schemes of telemedicine services remain vague, heterogeneous or even non-existent. Health funds are often held responsible for restrictions on the coverage and reimbursement of telemedicine services. While some telemedicine services are eligible for reimbursement, patients still bear the cost in the majority of them. In addition, reimbursement from health funds often takes place only if specific conditions are met (eg the service was provided in a doctor’s office or a patient was living in a rural area). As a result, non-transparent and complex reimbursement models lead to confusion: patients are not able to understand which services are reimbursable and to what extent often choosing to avoid telemedicine services altogether, however cheap and convenient.

The Directive 2011/24/EU on patients’ right in cross-border healthcareestablishes, in Article 7, the general rules on reimbursement for cross-border medical acts received and defines the conditions under which a patient may receive medical care and reimbursement from another EU country. Furthermore, Coordination Regulations (EC) 883/2004 and 987/2009 entitle insured individuals to receive healthcare elsewhere within the EU or EEA and in Switzerland. It covers healthcare costs, as well as the prescription and delivery of medications and medical devices as it would in their home country. However, healthcare reimbursement falls within the competence of the Member States. Therefore, the solution that is foreseen to the Directive should be fully adopted and specialised with specific and clear provisions by the national authorities.

Where do we stand with jurisprudence

The provisions of the Treaty on the Functioning of the EU permits Member States to restrict the freedom to provide medical and hospital services in so far as the maintenance of a treatment facility or medical service on national territory is essential for the public health and even the survival of the population. However, particularly, in the Kohll case C-158/96, the Court of Justice stressed that the requirement of prior consent by the insured person’s health insurance fund, before the patient can claim (ambulatory) medical costs in another Member State, is a barrier to the free delivery of services. The Treaty precludes national rules under which reimbursement, in accordance with the scale of the State of insurance, of the cost of (dental) treatment provided by an orthodontist established in another Member State is subject to authorisation by the insured person's social security institution.

It should be stressed that the rules on reimbursement are valid only if the treatment is available and covered in the patient’s home country, even if it is provided via telemedicine services. Unfortunately, national health funds are not obliged to reimburse the same telemedical acts. And even if they did, they may not necessarily reimburse for the same amounts or in the same proportions. Besides, a health fund has the right to refuse reimbursement of a patient if it deems that the medical treatment could have been delivered in the home country or even in cases in which prior authorisation was required but not requested. Also, the member state may pay just a part of the treatment, instead of providing total reimbursement, grounded on ‘overriding reasons of general interest’. However, all limitations imposed to the reimbursement must be necessary and proportionate and can never operate as a discriminatory mechanism or as an obstacle to the free circulation within the EU. Finally, another exception derives from Article 8, which permits the introduction of a system of prior authorisations for the reimbursement of medical expenses. Prior authorisation can only be demanded for treatments that require at least one hospitalisation night or require specialised and cost-intensive medical treatment. This exception can be easily applied to telemedicine, because of the complex and expensive technologies used. Prior authorisation may be also refused when grounded in objective reasons (eg excessive risk for the patient herself).

Patient rights must be secured

In general, most of the legal patient rights guaranteed for cross-border telemedicine services result from the abovementioned Directive. It foresees that patients are entitled to the following:

  1. The right to receive medical treatment in another Member State (art. 1) and, under certain conditions, to be reimbursed;
  2. The right to access one’s medical record, in written or electronic format (art. 4/2/f), containing all the relevant information related with the treatment received;
  3. If requested, the patient is also entitled to be informed about the standards and guidelines on quality and safety in place in the Member State where the treatment is provided or, in the case of telemedicine, where the physician is based (art. 4/2/a);
  4. The right to be informed on the availability, quality and safety of the service used, as well as information on the authorisation or registration status of the tele-provider (art. 4/2/b); and
  5. The right to have transparent complaint procedures implemented, for patients to seek remedies if they suffer any harm from the treatment received in accordance with the legislation of the Member State of treatment, i.e., where the healthcare provider is located (art. 4/2/c).

The benefits of telehealth services

Remote group collaboration; improving the overall quality of the services; the possibility to expand the spectrum of medical service; facilitating the patient’s direct access to a faraway doctor, without requiring displacing anyone – these are true and lasting benefits which elevate telemedicine to a revolutionary change in the way people give and receive medical assistance. It is not only more convenient for the patient, who is able to keep up with her daily life, reducing hospitalisation and the overall treatment costs. It is also helpful in better ensuring patient safety, by avoiding some unintentional human mistakes, such as errors derived from the inability to read doctor handwritten prescriptions. Concerning the latter, the Greek Ministry of Health lately ordered, due to the Covid-19 pandemic, obligatory electronic prescriptions, especially for patients that belong to vulnerable groups (eg adults 65+, cardiopathy patients etc.). Treating physicians may re-issue monthly or recurring prescriptions, for these categories of patients, for up to three repetitions, relating to a fixed medication that chronically ill patients receive and which will be provided by the pharmacies.

Conclusion

The recent Covid-19 outbreak made government health agencies take significant steps to encourage more doctors and patients to use telemedicine tools.

Their aim might have been to reduce the potential exposure of vulnerable groups to the virus.  But the net effect may be long-lasting and industry-shattering.

The final objective is to turn telemedicine into a standard medical service, secure and accessible to every European patient and fully covered by their respective social security systems. What is still pending however, is for the EU to take steady steps towards establishing a clear and harmonised legal framework for telemedicine that will boost the confidence of both patients and physicians and bring into life the European dream of the coveted EU patient health record.

________________

Telemedicine: The legal framework (or the lack of it) in Europe, Vera Lúcia Raposo, August 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987488/

Market study on telemedicine, European Commission, October 2018, https://ec.europa.eu/health/sites/health/files/ehealth/docs/2018_provision_marketstudy_telemedicine_en.pdf

Health Systems Governance in Europe, The Role of European Union Law and Policy, 13 - The EU legal framework on e-health, Stefaan Callens, August 2010, www.cambridge.org/core/books/health-systems-governance-in-europe/eu-legal-framework-on-ehealth/3A111704891E2C82A98FC361C9D04763

Telehealth rules relaxed, but patients still face barriers, Alison Kanski, April 29, 2020, www.mmm-online.com/welcome/77570/single/~home~channel~regulatory~telehealth-rules-relaxed-but-patients-still-face-barriers

Telehealth’s future is bright. Here’s what it’ll look like in 2025, Mark Sullivan, June 2020, www.fastcompany.com/90505924/telehealths-future-is-bright-heres-what-itll-look-like-in-2025