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Telemedicine and remote medical services
Mannheimer Swartling Advokatbyrå, Stockholm
Mannheimer Swartling Advokatbyrå, Stockholm
The Swedish healthcare system is currently under a lot of pressure due to the Covid-19 pandemic. It is therefore important to take measure to ensure that the healthcare system can keep up with the developments and meet the ever changing needs of citizens.
At a time when many people exercise voluntary quarantine or isolation and movement is restricted, the demand for medical services has changed. Given the risk of contracting severe illness from the coronavirus, certain patient groups may not be able or willing to physically visit hospitals or other large healthcare facilities during the pandemic. It could be because of old age or a serious underlying medical condition. It is now perhaps more important than ever to ensure that everyone can access the healthcare system and get the medical attention they need. This could be achieved by finding and advancing alternatives to the traditional ways of providing healthcare.
Solutions offering remote treatment – such as telemedicine – from patients’ homes could be a valid option for certain conditions and medical need. Other solutions, such as offering off-site treatment in smaller clinics than the large hospitals, appears to be a good and rapidly evolving alternative for specific patient groups at high risk of contracting severe illness from the coronavirus.
This article aims to provide an overview of how medical services and the needs of patients have developed during the Covid-19 pandemic. The article will also reflect on possible outcomes and further advances of these developments and possible changes to the legal framework.
Telemedicine offers remote health care and refers to the practice where medical services are provided when the healthcare professional and the patient are not physically present with each other. It includes medical consultation conducted by phone or video chat, for example.
Telemedicine has been available on the Swedish market for many years. Telemedicine has however come into focus even more over the last few months. Swedish regions, which are responsible for ensuring that appropriate healthcare is available to all Swedish citizens and residents, report a very strong increase in the use of telemedicine services compared to previous years, ranging from renewal of prescriptions to medical consultations involving diagnosis, treatment etc. The increase in demand extends to both private and public healthcare providers. There can be little doubt that this increase is a result of the Covid-19 pandemic.
Healthcare providers offering telemedicine are subject to the same national rules as healthcare providers giving medical care in the traditional sense. The Swedish National Board of Health and Welfare did however lay down specific guiding principles in 2018 for the provision of telemedicine. The principles provide that telemedicine may be used only where applicable law or medical experience do not implicate that a physical visit is required, the remote medical service is tailored to the patient’s individual needs and ability to use the service, the healthcare provider has sufficient information on the patient’s medical condition, and necessary follow-ups and coordination with other caregivers are possible. Also, when using digital health services, the Board’s regulation HSLF-FS 2016:40 stipulates that if ‘open networks’ (eg the internet) are used in the processing of patients’ personal data, each health care provider is responsible to ensure the safety of the personal data contained in the system, including by use of a two factor authentication method for remote connection to the system.
It is evident that the applicable healthcare legislation in Sweden is designed with the traditional way of providing healthcare in mind and that the legislator has not kept pace with the digital developments. The legal framework focuses on the organisation rather than the patient’s need. This could hinder the development of personalised care and innovation. The current regime renders collaborations and joint solutions between healthcare providers difficult. National strategies and governance are required to create conditions that will allow telemedicine to use its full potential. Structural changes, facilitation of exchange of information and harmonised information systems, investments, and collaborations between different healthcare providers are examples of possible measures that could be considered by the legislator to secure quality and improve the provision of telemedicine.
Even if the legislator has fallen behind, the ongoing Covid-19 pandemic has required adoption of temporary measures facilitating telemedicine, to limit the spread of the coronavirus and to be able to handle the pressure put on the healthcare system. As an example, the Stockholm Region, being responsible for all publicly-financed healthcare in Stockholm, which has been experiencing tremendous pressure from the Covid-19 pandemic, has adopted provisional measures. Examples include allowing digital patient visits in more areas within healthcare and adjusting the compensation to healthcare providers for such remote consultations.
The Government held in the Digi-physical Health Inquiry of 2019 that telemedicine could offer efficiency, accessibility and quality improvements to healthcare. It is an objective of the Swedish Government that Sweden shall be a world-leader within the area of eHealth in 2025. It could also free medical resources and contribute to a more equal healthcare, which is a main goal under healthcare legislation. It is evident from the ongoing situation that the conditions for changing the rules to better facilitate telemedicine exist. Seeing the benefits of telemedicine, the Government and other public authorities should take this opportunity to evaluate the benefits of telemedicine and, hopefully, suggest necessary amendments in the legislation.
Furthermore, as the general public’s attitude and propensity to use telemedicine are changing during the Covid-19 pandemic, the public could be more likely to have confidence and feel safe in using telemedicine and, to a greater extent than before, also to keep doing so in the future. Both healthcare professionals and the general public could perhaps see the perks of telemedicine, whether it would be for fear of spreading diseases, not wanting to expose oneself to the risk of contracting a virus, convenience, or any other reason.
The Covid-19 pandemic has clearly had an impact on the way medical services are provided. Although many of the measures taken are temporary, the general public’s demand for remote healthcare services could undergo an enduring change, having permanent effects on the healthcare system. It is safe to say that telemedicine has been given a real boost during the pandemic and it is the responsibility of public authorities and the legislator to keep abreast with the developments and to make necessary amendments to ensure that Swedish healthcare can claim place as world-leading within eHealth, which the Government aims to achieve.
Virtual clinical trials
A demand for remote medical services has emerged also with respect to research activities. The Swedish Medical Products Agency (MPA) recently received a grant to study the conditions and requirements for virtual clinical trials. Although the study is not initiated as a direct result of the Covid-19 pandemic there should be little coincidence that it got the green light at this time.
The study aims to change the way clinical trials are conducted – both on a national and international level. One expectation is that virtual clinical trials could give more patients an opportunity to participate in clinical trials. Virtual clinical trials could also broaden documentation and thus support the development of innovative drugs and could facilitate more equal and economically sustainable clinical research.
The preliminary study will be conducted in both a theoretical and practical setting and in close interaction with interested parties, typically those who initiate, plan, and conduct clinical trials. The study is due to run until February 2021. If the MPA concludes that it considers clinical trials with certain virtual elements to be a good option, updates to the relevant rules and guidelines are to be expected.
It should also be noted that a guidance on management of clinical trials during the Covid-19 pandemic has been published under the lead of the European Medicines Agency. The guidance recommends certain measures that could to be taken during the pandemic, if necessary. Among other things, the guidance stipulates that where a trial participant is unable to attend the trial site, other measures, such as contact via phone or the internet, could be required. Although the MPA has made no official statement, the MPA refers to the guidance on its website and it is possible that the MPA considers it in the preliminary study.
Off-site treatment solutions
A trend could have started to emerge, which entails that actors in the life sciences sector seek to collaborate and find solutions for off-site treatments for specific patients at high risk of contracting severe illness of the coronavirus. Many such patients cannot await a safer hospital environment to receive their treatment, while they are also particularly important to protect from potentially serious contagious diseases. It is especially important for these groups that solutions can be found for providing their required treatment in a safe manner.
Enabling and facilitating off-site treatment, for example within the scope of public healthcare or by prospective collaborations between healthcare and industry organisations, could help protect vulnerable patients from getting infected with the coronavirus, by finding ways for these groups to avoid frequent visits to hospitals.
If off-site treatment programs are deemed successful, it is possible that smaller specialised treatment clinics will become more common in the future, and to a greater extent integrated with the regular operations of healthcare providers. This could advance safe, high-quality treatment for particularly vulnerable patients.
Many of the outlined developments could bring efficiency, accessibility, quality and personalised care to the Swedish healthcare system – in line with the goals set out in the legislation. To support the developments, the structure of the legal framework must be changed to better facilitate and advance measures such as telemedicine and other remote medical services and off-site specialised treatment. It is mainly up to the legislator and public authorities to make sure that the healthcare system meets the people’s needs and demands.