Clifford Chance

Some medical treatment can be carried out using digital technology without a doctor being physically present. But what legal challenges does the use of digital technologies entail? This is an issue faced by stakeholders across the global healthcare sector.

Digital technology is opening up promising new avenues, particularly in healthcare. It is creating new markets and significant opportunities for companies in areas such as telemedicine and the remote treatment of patients. At the same time, digital technologies can potentially save costs, improve quality and expand available medical care, as well as democratising patient care over the long term.

Telemedicine services are widely used and we are already seeing the use of AI, robots or robot-assisted applications. The technology exists, for instance, for radiological examinations or surgical procedures to be performed without the doctor having to be in the same room, in the same hospital, or even the same country. However, it is often impossible to exploit the potential of these digital innovations in the healthcare sector because legal regulations and/or professional standards (for example, those set by medical associations) do not adequately reflect new technological developments.

There is not currently any specific legal framework for inpatient treatment where doctors are physically separated from their patients and potential legal challenges are faced by all stakeholders involved – not just healthcare companies, hospitals and medical staff, but also health insurance companies and legislators.

DIGITAL HEALTHCARE – A GROWTH MARKET

The digital healthcare industry is expected to continue to see strong growth worldwide with an expected annual turnover of up to one trillion euros. The market potential for telemedicine for 2030 (which includes teleconsulting, telemonitoring and other telemedical applications), is predicted to be up to EUR 3.6 billion. In addition to the obvious potential for savings, telemedicine is a solution to healthcare bottlenecks resulting from demographic trends and the shortage of doctors and specialists (particularly in rural areas).

POTENTIAL AND OPPORTUNITIES

In the future, it is entirely possible that specialists – who are fully responsible but in a different location to the patients being treated – will operate robot-based or robot-assisted devices remotely. 

This would significantly increase treatment options, especially in areas with a low density of doctors having the required expertise. Patients could eventually deal with healthcare professionals located in another country or even on another continent. This could help relieve situations where insufficient healthcare provision is available, reduce hospital admissions, cut treatment and staff costs and also improve quality of care and democratise healthcare provision.

THE CHALLENGES OF REMOTE INPATIENT TREATMENT

Providing inpatient treatment remotely entails a number of legal issues and challenges:

Ban on remote treatment

As remote treatment is not permitted under many professional regulations in many jurisdictions, doctors often advise and treat their patients in person. Providing advice or treatment exclusively using digital and other communication channels is often only permitted in individual cases and under certain conditions. In particular, therapy involving remote treatment must be appropriate and necessary according to medical standards. Whether this applies in a specific remote setting is subject to a case-by-case legal review.  

Remuneration

If several service providers provide remote services at the same inpatient location, this often leads to remuneration conflicts, such as the question of who is entitled to bill for which services. In certain cases, a specific agreement may have to be reached on the reimbursement of costs in order to ensure that all parties involved are paid (i.e. the hospital and the doctor working remotely).

Product liability

If medical devices are used in a remote setting, product liability aspects also need to be taken into account. With new technologies, particular attention must be paid to ensuring that the instructions for use and hazard warnings are sufficiently detailed and comprehensive to avoid errors. In addition, a particular liability risk may arise if interconnected devices cannot establish a sufficiently stable connection due to design or manufacturing errors, though the manufacturer is not responsible if this issue is down to a poor internet connection (for example, in a hospital).

 Further legal aspects

Remote treatment generally involves processing patients' personal and health-related data, so data protection requirements also have to be observed. Depending on the design and use of digital technologies, both sensitive health data and personal data relating to patients, doctors and healthcare professionals may be collected and processed. There may also be legally required security measures to consider when implementing new IT infrastructures. Failure to meet safety requirements properly can give rise to liability risks that affect all of the parties involved, especially hospitals, and medical device manufacturers.

Using a remote-controlled device often involves providing or using services that enable communication via image or sound, so compliance with telecommunications and telemedia regulations is important. In some case, medical device manufacturers might be categorised as providers of communication services, which could trigger a whole different set of obligations (such as having to appoint a safety officer in some countries).

There are also many other legal aspects that may be relevant depending on the remote setting (such as special requirements in tele-radiology if the radiologist is not at the same location as the patient during the radiotherapy treatment).

WHAT's NEXT?

Digital technology in a remote inpatients' setting offers higher quality, more comprehensive care to a broader range of patients and can cut costs and reduce the burden on health insurance companies. However, the complexity of the current legal framework poses major challenges. Given the rapid digitalisation of the healthcare system, legislators and professional organisations need to take decisive action to adapt legal and professional requirements to the new technological possibilities and, ideally, move as quickly as the innovation itself.