Nowadays, imagining a world with no telemedicine would be difficult – having different forms and definitions around the globe, it became an essential practice of medicine. What laws has it been enacting and what regulatory challenges does it still have to face?
Many countries have been broadening their laws and lifting restrictions on virtual care to rapidly enable their citizens the access to basic healthcare services during the lockdown: online consultations, diagnoses, and prescriptions. A great number of them will be reimbursed by the corresponding public health systems or covered by private insurers. This, as well as many other telemedicine details, has recently got regulated by different local laws and legislations.
From just an option to essential service – last year was game changing for healthcare accessibility in many developing countries. Bangladesh, where there is no legislation on telemedicine, but where the government encourages its practise, is one of them. Offering teleconsultations, medical advice, treatment, and e-prescriptions via mobile applications and internet platforms, it has enabled medical services to many of those who didn’t have access to them before1. Some barriers, such as limited mobile or internet connection, are still an important challenge to face.
However, not only developing countries took advantage of the situation. One of those countries where the pandemic – causing rapid development and implementation of telemedicine – made a great shift in the local healthcare system, is the US.
Already in March, facing the medical emergency and still having tight telehealth restrictions, the U.S Department of Health and Human Services decided to lift penalties for HIPAA (an act created to protect the privacy and security of protected health information) violations against healthcare providers. The nationwide resolution was followed by the decision of the federal Centers for Disease Control that published new telehealth regulations corresponding to each state.
A wider standardization of virtual healthcare wasn’t imposed by the European Union, although a great number of Western and Central European countries did broaden their telemedicine laws in similar manners when facing the pandemic.
France, for instance, together with Spain and the UK, allow healthcare practitioners to issue e-prescriptions during a teleconsultation and, in particular cases, obtain the medicine via delivery. On the other hand, in the Netherlands, an electronic prescription can be offered only to those patients, who have already personally met the prescriber or whose doctors have a detailed record of their medical history2.
Apart from prescriptions, what is commonly allowed within telemedicine in Western European countries is telephone or electronic consultation, telemonitoring, diagnostic, and, as in the case of France, telexpertise and teleassistance, among others.
Nevertheless, many countries still have no definition of their understanding of telemedicine, that very often goes with the lack of assigned telehealth national entities. In those cases, the bodies responsible for the regulations are usually Health Departments, Ministries or authorised boards.
Some, but still few countries, appoint their proper governmental units that subject telemedicine. One of them is Saudi Arabia that already in 2018 formed the Saudi Telemedicine Unit of Excellence that monitorizes its development and regulations on the national level3. The specification between regulations on national and transnational level is in this case crucial – Saudi Arabia allows foreign healthcare practitioners to provide telemedical services on their territory, however only under the local supervision. Number of different countries, including various EU’s state members, don’t.
Problems with definitions
Among various points national governments have to specify in the context of telehealth regulation, there is an important question that has to be answered first – what actually is the practice of medicine according to the local law and how does telemedicine fit within it?
Depending on a country (or federal government in some cases), medical practice can range from examination and diagnosis to treatment and issuing medical documents, including prescriptions. Not always defined as a face-to-face consultation, it gives a certain latitude for telemedicine, however more likely national than transnational one.
To specify this point, an important question has to be asked: who is authorised to offer medical practice within every territory and to what extent? Medical practitioners coming from different national backgrounds will have different qualifications and licenses, not always meeting the local requirements in other places. So, for instance, can an Italian doctor examine and prescribe treatment to a French person located in France?
In this particular case, yes, as Italy is part of the EU and France allows doctors from other member states to practise medicine on their territory (even though it won’t be reimbursed). Nevertheless, this practice isn’t standardised and varies by a country – both within the European Union and globally.
Why not standardised yet?
The complexity of the standardization and regulation of telemedicine comes from different issues that have to be precisely concerned. These are, among others, the question of billing, liability, fraud or even intellectual property protection. There are numerous regulatory challenges that globally still have to be faced when it comes to making both national and transnational telemedicine lawful. And yet there are no confirmed international jurisdiction plans that would make the standardization faster and easier for local governments.
Global health crises like the one we live in nowadays, make the topic more current and each year more important. Transnational communities such as the European Union refer to telemedicine in various directives and recognise it on different levels, however do not interfere with the regulations of each member state. And it’s still considered pending for the EU – working on a general legal framework that would increment confidence and lawfulness of telehealth.
- Telehealth around the world: A global guide – DLA Piperwww.dlapiper.com › insights › publications › 2020/12