Regulatory requirements for telehealth, telemedicine, and telecare vary between countries and jurisdictions. Although telemedicine has been available in many places for some time, the sudden upsurge in demand during the COVID-19 pandemic has accelerated and broadened its use, with the regulatory aspects relating to it attempting to catch up. There are different types of regulators in each country. In the UK, the General Medical Council (GMC) is the regulatory agency for doctors, while the main healthcare regulators are the Medicines and Healthcare products Regulatory Agency (MHRA), the General Pharmaceutical Council (GPhC), and the Care Quality Commission (CQC). On an international scale, most regulators agree that telehealth and telemedicine are concerned with providing healthcare services remotely via ICT, and don’t consider them to be a separate specialty in their own right. However, as the specifics of these terms are generally not defined in law they’re very much open to interpretation. Some regulators are of the opinion that telemedicine only encompasses healthcare services which use multi-modal interactions (such as a video consultation with accompanying audio), and don’t consider a single mode during an interaction to be telemedicine even if it is synchronous (such as a telephone consultation).
Others argue that any asynchronous interactions shouldn’t be classed as telemedicine at all, and some have developed particular rules pertaining to clinical investigations which are managed remotely.
There is some common ground between regulators: it’s an almost universal requirement that a telemedicine practitioner has to be a doctor who holds a licence to practice medicine as issued by the relevant authority. Although many interactions take place in the context of a doctor-patient relationship, most regulators acknowledge that telemedicine can also be used between doctors — including as a referral system and a teaching tool. There’s the general expectation that usual standards of good medical practice will be adhered to, including assessing the suitability of a telemedicine consultation for that particular patient’s needs, obtaining consent to proceed, accessing their medical records, achieving the same standard of care regardless of the mode of delivery, maintaining confidentiality, ensuring a secure and efficient transfer of information, arranging an in-person follow up if necessary, and reporting any clinician licence violations via the usual channels.
The current GMC guidance for remote consultations advises that the mode of delivery used for healthcare services must be an appropriate method of providing care to the patient. It also states that doctors should have a low threshold for seeing patients in-person if:
- they have complex clinical needs
- there’s limited access to their medical records
- the doctor is not their usual GP
- an examination is necessary
- there are doubts regarding mental capacity
- there are issues with communication
- the discussion of treatment options cannot be properly explored remotely
The CQC recently reported that their main telemedicine concerns are centred around patient identification using key characteristics, the accessibility of medical records in advance of any consultations taking place, and monitoring the use of asynchronous data. They’re also keen to ensure that any requests by patients for confidentiality of sensitive information are considered and weighed in context, so as not to allow abuse of the system or prevent sharing of important information for improper reasons.
The GMC 10-step guide of high level principles provides advice for any practitioner when prescribing medications remotely:
1. Patient safety must be your first priority
2. Make sure you’re able to identify and protect vulnerable patients
3. Introduce yourself and explain how the remote consultation will work
4. If the prescribing process is unsafe (due to a lack of shared information or the medium of telemedicine itself) the patient will need to be referred to other services
5. Compliance with informed consent practices and mental capacity regulations are vital
6. Adequate clinical assessment and reference to medical records must be undertaken, with further examination and testing if necessary
7. Communicate the patient’s options to them in an understandable format, including their right to decline treatment
8. Arrange follow-up care and sharing of information appropriately
9. Keep clear contemporaneous records explaining and justifying any decision-making
10. Keep up-to-date with remote learning, training, and guidance
International regulations governing telemedicine are variable at best — many use existing Public Health or Information Technology regulations with no specific remote-working legislation. As each jurisdiction and country has different ideas regarding telemedicine in general, there are more and more points of contention emerging around the use of telemedicine across borders.
A major regulatory consideration for a doctor arises if they choose to remotely treat a patient in another country or jurisdiction which has different telemedicine regulations to their own. There has been much debate as to whether the rules of usual medical practice and prescribing should be applied based on the location of the doctor, or the location of the patient. It is the doctor’s responsibility to ensure they are working safely based on both countries’ laws and that they have sufficient indemnity to do this. Both the licences and the accessibility of certain medicines vary significantly from country to country, and if these need to be imported or exported it can pose challenges to effective patient care. The use of cross-border telemedicine raises concerns around international transfers of patient data, which may not be permitted even with the patient’s written consent. Within the European Economic Area (EEA) specific GDPR rules apply to the disclosure of healthcare information, and many other countries have similar laws in place. There is also the question of whether cross-country remote second opinions (RSOs) between doctors are legal if their countries have differing telemedicine rules. There are concerns from regulators that substandard care by a doctor could be difficult to identify and investigate if they work in another country, with further issues if disciplinary measures or sanctions needed enforcing.
Other regulatory requirements which must be considered include the use of telemedicine devices themselves. This generally relates to any equipment which provides care to the patient in a remote fashion, such as monitoring and communication devices, and product licences vary between jurisdictions. There is also the issue of funding — some governments subsidise or reimburse healthcare providers to undertake their duties, which they may be reluctant to do if increasing numbers of those benefiting from telemedicine are not resident in their own jurisdiction.