Just what the doctor ordered
In a follow-up to her article in the August/September Gazette, Áine McCarthy explores the practical challenges and opportunities faced by physicians regarding cross-border telemedicine.
The number of expatriatesaround the globe is continuing to increase, despite the pandemic. According to leading insurance and healthcare analyst Ian Youngman, there are now 80 million expatriates, 5 million international students, 4 million temporary foreign students, and 18 million high-net-worth individuals, of whom 2.7 million are ultra-high net worth. A Legatum Institute report estimated that there were 258 million people living outside of their country of birth in 2017, showing an upward trend from 173 million in 2000.
One of the key priorities of most expatriates before making the move abroad is to have sufficient international health insurance and access to quality healthcare. Since the pandemic, in almost every country, the state healthcare network is under never-before experienced pressure, so access to private healthcare is increasingly vital. In some countries, expatriates are finding it increasingly difficult to access state healthcare, with access to private healthcare becoming more and more strained as some hospitals prioritise healthcare for larger companies over one-time private patients.
The pandemic also accelerated the move towards remote working across the world, forcing people to embrace technology in new ways. The increasing strain on the healthcare system, coupled with the move towards a more digitally focused way of living, has revolutionised access to healthcare, and there has been an accelerated use of transnational telemedicine, whereby more doctors are seeking to serve patients across borders.
In addition to the regulatory challenges of telemedicine, there are practical and legal challenges for physicians practising remote telemedicine from abroad.
Place your hands
Once upon a time, a physician’s practice relied in large part on ‘placing a healing hand’ upon a patient, feeling the heart rate at the wrist, listening to the chest, and palpating the abdomen. In this digital age, physicians now have remote access to ECGs, X-rays, and ultrasound. The pandemic has proven how much of what doctors do in this current age can be done from a distance: it is no longer the case that the practice of medicine cannot be performed safely at a distance. Physicians can now review X-rays, vital signs, heart monitors, and blood tests remotely.
The border between one jurisdiction/country and another does not change the investigation and management of illness. By removing these barriers, physicians have access to larger populations of patients with similar conditions, which also massively increases the potential of recruiting candidates for clinical trials, and thus developing novel therapies or potential cures for rarer conditions.
For the individual patient, the removal of geographical barriers to accessing medical attention is incredibly beneficial. It democratises healthcare in a way that has been to date impossible as, historically, health outcomes have been closely tied to geographical location, with more remote populations being significantly affected. Where remote medicine can play a role is in the provision of specialist opinion – for example, a physician practising in a very specialised area could advise doctors in a remote part of the world on how to manage a rare condition or monitor progress.
As less and less of day-to-day medical practice requires the patient to be sitting physically across from the doctor, cross-border telemedicine has the potential to massively expand the reach of physicians and allow them to treat and manage patients with conditions within their fields of expertise, irrespective of their geographic proximity to the physician. The management of the patient and what is done with those results is where the difficulties lie.
Doctor alibi
Despite the lack of difficulties in the modern era with managing patients remotely, the realities of managing patients across borders continues, at times, to have its challenges, mainly in the more bureaucratic areas, such as the ordering of investigations or accessing results.
Over time, these issues should become less problematic, as new more streamlined systems are developed. In some locations more than others, there are many legal hurdles in place that limit the potential to practice cross-border telemedicine at present. The US is a prime example, where, by limiting medical indemnity cover and licensing physicians to practise in one state only, the role of cross-border telemedicine remains significantly affected.
A major issue for physicians when conducting remote tele-consults is who implements that advice, and who is legally responsible for the outcomes if one doctor advises a course of action and another (local) doctor orders those investigations and follows through on the course of action?
Another issue is how their advice is followed by the patient, and the identification of who takes responsibility for following through on advice given (for example, who physically provides the prescription and/or organises referrals and ongoing tests?) In particular, how can the patient access the investigations being suggested, or fill a prescription for the medicine the doctor recommends? This would require a local presence to implement these recommendations and, in reality, there are very few doctors who are willing to blindly follow the advice of another doctor and prescribe or investigate based on this.
In addition, at what point does a doctor’s advice become a legal ‘medical opinion’? If asked in a corridor by a friend about their sister, does what is suggested by a doctor carry a legal responsibility? If advised against attending the emergency department, what then happens if the ‘acquaintance/patient’ then becomes very unwell? All these questions are highlighted by the new practice of telemedicine.
So, while remote telemedicine has a lot of appeal and has the potential to democratise healthcare globally in a way that has been, till now, an impossibility, the reality is that physicians are still stuck with as many questions as answers.
In order to maximise the potential of remote cross-border tele-medicine, one needs to look outside the basic premise of ‘reviewing a patient remotely’ towards more exciting possibilities, such as in the clinical trial space – combining the remote capture of data, the global expertise and wealth of knowledge, and the power of the collective that can be achieved when working across borders.
Medicine man
Of those individuals with any condition of interest, only a fraction will meet the criteria required to enter into a clinical trial. Clinical trial-matching refers to the recruitment process, whereby a potential trial candidate’s characteristics (condition, symptoms, results, comorbidities, etc) are assessed against the eligibility criteria of trials that are currently recruiting.
One way of increasing recruitment is to broaden the eligibility criteria to enable more patients to participate. However, in order for the trial to be successful in identifying its outcome of interest (for example, success of a new drug therapy or intervention, reduction in mortality, etc), patients must be carefully chosen. They must be homogeneous enough that the outcome can be identified, but diverse enough that these results can be extrapolated to the broader patient populations.
Obtaining regulatory/ethics approval to run any clinical trial is required. Generally, each centre involved in the trial must obtain this approval – thus, increasing the scope and size of a clinical trial increases the number of institutional review boards that must approve the trial before trial-matching can even begin. The challenges within clinical trial-matching across borders are difficult from a legal perspective, given that each country has its own set of regulations relating to ethics approval, which do not easily facilitate multiple sites being involved. From a global perspective, the lack of common rules, procedures, and research ethics boards can add significant cost and inefficiency.
Differences between insurance and indemnity requirements across borders adds to the complexities of cross-border clinical trial-matching. Additionally, global/cross-border access to trial drugs must be considered before undertaking cross-border trial-matching. This may require substitutions in certain cases, as some drugs are not permitted to be imported from one country to another.
Other issues that may arise include language barriers and translation of regulatory materials.
Remedy
It is clear that much more work is required to streamline the process. Single authorisation sites that cover multiple countries would certainly have a huge impact. However, outside the EU, regulatory challenges are harder to address. Ideally, a central regulatory entity with global representation would exist, although this is not currently a reality.
Again, the more that indemnity and insurance requirements can be consolidated and standardised, the more the cross-border clinical trial-matching process can be streamlined, making it a legal reality. Centralisation of adverse report monitoring would equally subvert some of the current concerns with remote/cross-border clinical trials.
In order to overcome concerns about training and accreditation of researchers, the implementation of effective information technology and the use of online training systems is necessary.
Dr Feelgood
From a population perspective, the increasing capacity to practise remote telemedicine has huge implications for clinical trial recruitment and completion, with knock-on effects for the development of novel therapeutics and potential cures. At present, over 80% of clinical trials fail to reach recruitment targets. Trials are costly and time-consuming to run, limiting the drive to undertake them within research organisations and big pharma. Improving these processes with the use of telemedicine gives those running clinical trials potential access to a global cohort of patients, vastly improving chances of successful recruitment and trial completion.
One of the main goals of clinical trials is the generalisability of the results. By recruiting patients from multiple countries and ethnicities, this can vastly increase.
From a patient perspective, remote telemedicine again offers the chance to democratise access to trials and novel therapeutics that historically have only been available in large select centres, again drastically altering access to first-world medicine, irrespective of geography.
Doctor, doctor
A huge opportunity exists to move into the era of precision clinical trial-matching, where the data available on patients prior to their recruitment is significantly more granular (often at a genetic or DNA level). This, in turn, will revolutionise clinical trial-matching by vastly increasing the number of potential patients who are deemed eligible early on in the recruitment process.
Equally, by moving more into the global or cross-border space, where patients are able to be rapidly and effectively recruited and monitored, irrespective of geographic location, through the use of cross-border telemedicine, not only will recruitment and retention rates in clinical trials improve, but it will significantly improve the generalisability of trial results and global access to state-of-the-art therapeutics as they become available.
Look it up
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All views expressed in this article are the author’s own and do not represent the opinions of any entity whatsoever with which she has been, is now, or will be affiliated.
Áine McCarthy
Áine McCarthy is head of legal (international health) at Allianz Partners and is a member of the Law Society’s In-House and Public Sector Committee. She wishes to thank Prof Oran Rigby and Prof Amy Hollingworth (Akkure Genomics) for their input and suggestions.