Anticipated Reforms

On 31 May 2023, the MBA released its revised guidelines for telehealth consultations between medical doctors and their patients (Revised Guidelines), effective from 1 September 2023. The Revised Guidelines:

• Set out what a medical doctor must do before, during and after a telehealth consultation (including guidance relating to use of technology, ensuring patient privacy, and providing instructions to the patient if the technology fails);
• Note that the MBA does not support a medical doctor prescribing or providing healthcare where a patient has never had a real-time direct consultation (in-person or via video or telephone) with that doctor, which includes, but is not limited to, prescribing medication via questionnaire-based asynchronous web-based tools;
• Provide that telehealth consultations are not appropriate in all circumstances and therefore, do not operate as a complete replacement for in-person consultations; and
• Clarify registration requirements for medical practitioners who use telehealth to provide services across geographical borders.

On 16 February 2023, the Australian Attorney General released a report on the Privacy Act, containing 116 reform proposals.  Although the report did not target telehealth providers directly, below is a summary of the proposals relevant to telehealth providers:

• The collection, use, and disclosure of personal information must be fair and reasonable in the circumstances (when assessed through an objective lens);
• APP entities must conduct a Privacy Impact Assessment for activities with high privacy risks. The Attorney-General has requested that the OAIC develop guidance which articulates factors that may indicate a high privacy risks.  In this regard, it may be the case that telehealth providers may need to conduct Privacy Impact Assessment on its telehealth consults and/or recordings they have of patient consults (to the extent they keep any recordings);
• Additional protections must be provided for children and vulnerable persons, requiring entities to make collection notices and privacy policies ‘clear and understandable’;
• Individuals may have right to access, and obtain an explanation about, their personal information if they request it; and
• Amending APP 11.1 to ensure that ‘reasonable steps’ include technical and organisational measures, which may affect what technical measures will need to be implemented for telehealth consultations.

As the use of telehealth grows and becomes more mainstream the Australian medical sector it is possible that specific guidance on privacy issues in the context of telehealth may be developed to complement the current obligations set out in the Privacy Act (and applicable surveillance laws), but there has been no public indication to date that such developments are imminent.

The Austrian Medical Chamber has raised the need for a legal frame for telemedicine and e health. A legislative initiative on these issues has not reached parliamentary discussion yet and we are not aware of any near changes in this regard.

We are not aware of any specific laws, regulations, or self‑regulatory instruments expected to be adopted in Bahrain in the near future.

Please note that the above is based on a high-level desktop review of the relevant regulations and no ministerial enquires have been made to confirm the position.

We do not have knowledge of upcoming regulations. However, we expect that there will be new developments in the coming months as telehealth and its possibilities have been under a lot of attention following the COVID-19 pandemic.

Additionally, RIZIV/INAMI is currently carrying out (or analysing the results of) test projects in the fields of teleconsultations, tele-expertise, telemonitoring, tele-assistance and m-health in order to assess the development of reimbursement frameworks.

Although we cannot anticipate any specifics, the expectation is that, with the new Brazilian Telehealth regulation (i.e., Federal Law n. 14,510/22), other subjects related to Digital Health will be even more debated and encouraged – e.g., digital prescriptions and remote diagnostic tests (Point-of-Care Testings - PoCTs), as well as remote request for dispensation of medicines. Also, in order to prevent ideological aspects from jeopardizing the benefits that telehealth can undoubtedly provide to the Brazilian population, the Brazilian Telehealth regulation expressly required that any normative act that intends to restrict the provision of telehealth services shall demonstrate its “indispensability to avoid damages to the health of the patients”. This way, another expectation is the review of many norms already published by Professional Boards that restrict remote assistance in a broad way without any exception.

Indeed the myriad of legal issues that digital health faces in the region is wide ranging but the process of incorporating it into business practices is still in early days. We believe much more development is to come, but even today the use of IA and IoT open source, high-quality, and deidentified data, in addition to a sustainable approach to expanding access to health, shows how the strongest healthcare players operating across Brazil and Latin America are addressing procompetitive risks and distinguishing themselves from the less agile pack.

This matches our understanding that, considering the current and global backdrop, as well as the great expectation of greater expansion in the coming years – mainly with the advent of 5G and artificial intelligence -, this is the time for the stakeholders that make up the chain of healthcare services and systems worldwide to direct efforts in the development and strengthening of the digital health ecosystem in a timely, safe, and innovative way.

Besides, early indications already suggest that, given the inconstancy verified in this multifaceted market, sustainable strategies are needed for companies to effectively operate and thrive. This also rings a bell in the sense that the companies operating in this field through disruptive business models must protect and explore the opportunities that the technology offers behind their products and services. This is, by the way, a great investment hub, especially in this new era of informatization and data monetization – mainly in Latin America.

No.

Over the years, various health care authorities, associations, and task forces have updated their virtual care policies. For example, a new standard of practice for virtual medicine implemented by the College of Physicians and Surgeons of Manitoba in November 2021 requires a blended model of care balancing in-person and virtual care delivery, and explicitly states that examples of virtual care that do not meet the standard include physicians not offering in-person appointments, including during a pandemic, unless advised by a health authority to not see patients in person; virtual medicine–based businesses that do not offer timely in-person appointments by the same physician; and physicians unnecessarily restricting in-person visits with patients or having very limited in-person appointments.

On March 17, 2023, Law No. 21.541 came into force, which updates the current regulations with the aim of authorizing health care providers to provide care through telemedicine. Specifically, the main modifications are in relation to Law No. 20,584, which regulates the rights and duties of individuals in relation to actions related to their health care.

In this way, the health industry is required to adapt the technology developed and marketed to technical and operational standards for its use in health care services.

Based on the above, we highlight the following amendments introduced by Law No. 21,541:

Information and Communications Technologies

The means through which digital health actions and services are carried out must be appropriate to the type of service to be provided to the patient.

The electronic medical record and the systems that support it must be designed to interoperate with other systems in the provision of health services.

The technological platforms used in digital health services, as well as those that store and process personal data, must be accredited on the basis of technical norms and standards established by the Ministry of Health.

Patients' rights

Information: The patient has the right to know the characteristics and conditions of use of the technologies that will be used for digital health benefits throughout their treatment.

Portability: Patients, or persons with their authorization, may request the delivery, free of charge and without delay, of a complete copy of the information contained in the clinical record, in a structured format that makes its portability possible.

Consent: The patient's informed consent to receive digital health services may be given verbally.

Responsibility of the provider

It must use technical means that meet the required security standards at all stages of data processing.

It will have to keep the patient records or databases and protect their confidentiality for a minimum of 15 years.

It shall not be exempt from liability if the provider uses third party means for this purpose.

We are not aware such development in the near future but will closely monitor the legislation updates in this area.

On February 13th, 2023 the Colombian government submitted before the House of Representatives of the Congress of the Republic a health reform bill, which aims to improve and strengthen the General Social Security Health System and guarantee the provision of health services as a universal right through 5 axes:

1. Creation of a network of Primary Care Centers (in Spanish, Centros de Atención Primaria - CAP) in the country with a focus on preventive and preventive medicine.
2. Assignment of the execution of Primary Care resources to the Health System Resources Administrator (in Spanish, Administradora de los Recursos del Sistema de Salud – ADRES).
3. Improvement of working conditions for health workers.
4. Construction of a public online information system to ensure transparency of resources.
5. Reform of the Health Provider Entities – (in Spanish, Entidades Promotoras de Salud – EPS).

Regarding the provision of telemedicine and telehealth services, the bill contains dispositions aimed to the Ministry of Health for it to regulate technically and operationally the information and communication technology systems for the provision of these services, as well as to propose the technological architecture that will support them. It also introduces guidelines for health care providers for them to guarantee medical care through the use of technological tools and telehealth.

Thus, although this bill has yet to go through the entire legislative process, if approved, it could introduce modifications to the provision of health services in Colombia, including telemedicine and telehealth services.

According to the relevant authorities, the national strategy on the field of telehealth will be still subject to regulation and developed alongside the digitalisation of health system. Currently, there are no special legal acts in the public discussion or in a legislative procedure.

The Act on electronization of healthcare prepares the background for electronization of processes in health care with a view to making the electronic route the primary one and replacing paper-based agendas. The existing processes in the healthcare system are not changed by this act, the actual anchoring of the maintenance of medical records in electronic form is left in the existing regulation, especially in the Health Services Act.

The next phase of the electronization of healthcare should be the introduction of a health documentation index as an information system describing the basic typology of existing health documentation and bringing together metadata about the documentation.

The Danish Health Authority launched a "Strategy for Digital Health 2018-2022" in January 2018 focusing on the digitisation and use of health data in the context of prevention, care and treatment as well as development and research in the field of healthcare. The strategy consists of several initiatives including online standardised survey for patient reports, online rehabilitation on a regional and municipality level, and a guide to the use of the various existing healthcare apps.

Also, as a result of the financial agreements for 2016 between the Danish Government, the municipalities (kommuner) and the regions (regioner), the organisation ‘Joint Procurement and Development of Telemedicine’ was established. The organisation's first step in spreading the use of telehealth was focused on supporting the treatment of patients with severe chronic obstructive pulmonary disease. The goal was to subsequently expand the use of telehealth to other disease areas through infrastructure, and patient-related and employee-related solutions.

Thus, it is not unlikely that telehealth will be further regulated in the near future.

Any specific laws or other legal instruments relating to telehealth services are not expected to be adopted in the near future.

Relating to the future legislation in healthcare, the Ministry of Social Affairs and Health has drawn up a strategy for information management (Information to support well-being and service renewal e-health and e-social strategy, 2020). Healthcare services will be developed during the Health and Social Services Reform as part of the Future Health and Social Services Centres programme. The Health and Social Services Reform entered into force in the beginning of 2023 when 21 wellbeing services counties were established. One goal of the programme is to improve client-oriented approach to health services by introducing digital and mobile services. Therefore, the wellbeing services counties have and have had their own initiatives to improve accessibility by using telehealth services. The reform of social and healthcare services and the rising use of telehealth services may therefore add a need for renewals of healthcare legislation in the future as well.

Several laws, regulations and guidelines are expected to be adopted in the near future:

• Implementing texts have yet to be adopted concerning the new accreditation regime for teleconsultation companies;
• Conditions for reimbursement of telehealth procedures may evolve annually through the adoption of annual Social Security Financing Acts (Lois de Financement de la Sécurité Sociale);
• French authorities’ guidelines related to telehealth may further be regularly updated;
• Finally, further telehealth procedures may be recognized, or existing telehealth procedures may further be specified, under the French Public Health Code as professionals and patients rely more and more on telehealth as part of the usual healthcare pathway.

The telehealth initiatives of the German government have been highly dynamic very recently. According to the new German Patients Data Protection Act (“PDSG”), which came into force in October 2020, inter alia, from 1 January 2022, ePrescriptions shall be compulsory for physicians, dentists and clinics accredited by the Statutory Health Insurers ("SHI" – "GKV"), with certain exceptions. In addition, referrals to physicians and specialists as well as patients’ medical records must be available in electronic form, too. Furthermore, the patients’ comprehensive control over their personal data (including health data) and the requirements regarding the protection of the patients’ data in the context of the processing by, e.g., physicians, clinics and pharmacies is regulated by the PDSG.

Additionally, the new Digital Supply and Care Modernization Act (“DVPMG”) came into force in June 2021. The DVPMG, in particular, aims at digitizing healthcare in the area of nursing care. In addition to creating the possibility for patients in need of nursing care to use digital care applications on mobile devices or browser-based web applications to stabilize or improve their own state of health through exercises, e.g., fall risk prevention or personalized memory games for people with dementia, a new procedure will be created for reviewing the reimbursability of digital care applications. Furthermore, patients will be able to conveniently include data from telehealth applications into their electronic patient record (“elektronische Patientenakte”). Telemedicine services are now also available for other healthcare service providers than physicians and dentists, such as midwives. In addition, in the future, acute psychotherapeutic treatment can also take place in the form of a video consultation.

Besides that, the strict ban of advertisement for exclusive remote treatment under Sec. 9 of the German Act on Advertising in the Field of Healthcare ("HWG") has been lifted recently. Now, advertising for exclusive remote treatments is allowed, provided that in-person visits are not necessary according to recognised professional medical standards that apply in Germany.

In a recent decision, the German Federal Supreme Court (“BGH”) emphasized that the current requirements for in-person visits prior to telemedicine consultations could no longer be upheld in view of the needs of modern healthcare (cf. BGH, decision of December 9, 2021, docket no. I ZR 146/20). This may prompt German lawmakers to further amend the current telemedicine legislation.

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In October 2021, the Hungarian Government issued Government Decision No. 1619/2021. (IX. 3.) on the Government Action Plan for the implementation of the Hungarian National Social Inclusion Strategy 2030 for the years 2021-2024, which emphasizes the need to further develop telehealth services within the given period. This might result in amending existing legal instruments or making new ones.

There are no current proposals for specific laws, regulations or statutory instruments to regulate the telehealth space in Ireland.

However, the Programme for Government 2020 prepared by the Irish Government, has the delivery of care in a COVID-19 environment as a key priority. This includes learning from the healthcare response during COVID-19, continuing to deploy new technologies (including in relation to telehealth), and identifying innovative ways to support vulnerable groups, as well as new pathways of care. In order to deliver more care in the community, the Government intends to increase access to telemedicine and virtual clinics. Supporting eHealth, ICT, and digital health is another priority for the Irish Government, and the Government has set out a number of ambitious goals for their term. Although there are no legislative proposals set out yet, it is clear that this is a key strategic area for Ireland and there will continue to be significant developments in this field. Research conducted by Behaviour & Attitudes for the Medical Council has shown a five-fold increase in the use of telemedicine since early March 2020 by the Irish public and most of the people surveyed suggest that they will continue to use telemedicine more frequently in the future.

In light of the COVID-19 pandemic, the launch of the Sláintecare Strategic Implementation and Action Plan 2021–2023 and the cyberattack on the HSE, the Health Information and Quality Authority (HIQA) published a position paper on October 2021 proposing some recommendations on the reform of the Irish health information system, including on the provision of frameworks and guidance for the use of health apps and medical devices, the development of a new national health information strategy that will set achievable, time-bound objectives which align with the Sláintecare Objectives, as well as continuous investment and strengthening of a secure health information infrastructure.

The rules and guidelines issued over the last three years have significantly improved the legislative and regulatory framework governing telehealth.  On this basis, we expect that the Italian public sector will adopt and implement several telehealth solutions in the upcoming months and years. 

The National Telehealth Platform, which should be delivered for testing and startup by November 2023, aims at ensuring uniformity in the provision of telehealth services across Italian regions.  This will represent a major challenge for the Italian NHS.

No, for now.

Yes, depending on the development of the COVID-19 pandemic and other circumstances, it is expected that relevant government agencies may issue other guidelines regarding telehealth.

Yes. As already noted above, the Cabinet Secretary is required under the law to come up with Rules/Regulations to regulate the provision of e-health services in Kenya but none have been enacted to date.

The County E-Health Bill 2021 aims to provide a framework for the implementation of section 104 of the Health Act, the provision of telemedicine services and the establishment and management of e-health infrastructure and services at the national and county levels of government. The Bill is yet to be passed.

Further, in 2019, the KMPDC had drafted e-Health Guidelines which were intended to become the Regulations under the Medical Practitioners and Dentists Act. However, the Regulations are yet to be passed.

At this point we are not aware of when regulations on e-health will be enacted.

The codes of conduct on the use of telehealth systems and / or security of telehealth data in Kuwait are expected to be published soon.

To the best of our knowledge, no other Luxembourg legal provisions on telehealth services are expected to be adopted in the near future.

Given the current regulatory landscape in Mexico, there are no specific laws, regulations, and / or regulatory instruments expected to be adopted soon. This view is supported by the 2018 cancellation of the NOM Project mentioned in Availability of Telehealth.

Not applicable.

No, we are not aware of any laws, regulations or self-regulatory instruments in respect of telehealth to be adopted in the near future.  As for privacy and data, we anticipate privacy and / or data protection legislation to be passed within the next couple of years.   

In September 2022 a bill on the digital data exchange in healthcare was adopted (Wet Elektronische Gegevensuitwisseling in de Zorg (Wegiz)). The proposed Wegiz aims at achieving full interoperability in the electronic exchange of data between healthcare providers. It is a ‘framework act’ that makes it possible for the government to designate, by general administrative measures, data exchanges that must take place electronically.

We are not aware of any anticipated reforms on telehealth in Nigeria. However, there is a data protection bill which stakeholders expect to be passed into law before the end of the current legislative tenure.

No specific legal or regulatory reforms relating to telehealth are anticipated. We note:

• The New Zealand government is currently developing a new and comprehensive regulatory regime to control therapeutic products and medicines in New Zealand (see Therapeutic Products Bill). The Bill does not currently (and is not expected to) address telehealth specifically.
• The Medical Council of New Zealand is expected to publish an updated statement on telehealth once a recent submission process has concluded.

The Norwegian Directorate of eHealth is currently in the process of developing a new cloud based common medical journal system called the Akson, to allow for increased access for patients to their own information as well as improve interaction between emergency services, GPs, home care services and health stations.

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No specific instruments are known / expected at present.

There are no specific laws and/or regulations to be adopted at this stage. However, the Strategic National Plan for Telehealth 2019-2022 points out the review of the telehealth legal framework and identification of gaps as a priority in order to ensure operational conditions for the execution of telehealth.

The Portuguese Parliament approved new draft Resolutions on telehealth in 2021, in which it notably recommended the update and implementation of the Strategic National Plan for Telehealth approved in 2019, proposed measures for investment on telehealth and recommended measures to allow an actual implementation of the telehealth in the SNS.

The relevance of telemedicine in the Portuguese national context, particularly in the National Health System (SNS), has been highlighted in Decree-Law no. 52/2022, of 4 August, which establishes that SNS establishments shall “develop responses of proximity to the care needs at all levels of provision, considering equity, efficiency and quality objectives and using telehealth and home care, whenever appropriate.”

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We are not aware.

Presently, no.

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The HPSCA recently made amendments to the Guidelines to govern the remote management of patients using acceptable virtual platforms. The Guidelines allow healthcare professionals to provide telehealth services without a prior practitioner-patient relationship.

The HPSCA has stated that the guidelines are applicable during the COVID-19 pandemic, but that it will continue to fine-tune the guidelines around telemedicine (now referred to as "telehealth") governance in line with its mandate of protecting the public and guiding the (healthcare) professions. It is expected that the telehealth Guidelines will continue to remain in force into the future and that amendments to these Guidelines will be made by the HPCSA from time to time as the need arises.

Yes, as mentioned above, the telemedicine sector is due to be implemented in the course of 2023.

According to the Program Statement of the Government of the Slovak Republic for the period 2020-2024, the Government has stated that it is committed to support the introduction of innovative modern technologies, such as telehealth. The government will implement innovative ways of managing and financing general healthcare, although no changes in the area of telehealth are currently being prepared.

According to the Ministry of Health, the national strategy on the field of telehealth will be considered and prepared together with the strategy for digitalisation of health system in the following year. Currently, there are no special legal acts in the public discussion or in a legislative procedure.

Article 1(6) of the Slovenian Resolution on National Plan of Health Care 2008-2013 "Satisfied users and performers of medical services" had explicitly mentioned telehealth, telecare, Telepharmacy and other information technologies as one of the goals of the period at hand. However, the lack of legislation by 2020 shows that these goals were not reached.

The current document, Resolution on the National Health Care Plan 2016-2025, on the other hand, does not specifically address Telemedicine in great detail. Therefore, it can be assumed that the competent Slovenian authorities and legislator will not enact any new acts on the subject matter in the near future.

Regardless, the current COVID-19 pandemic and its effect on health services could potentially affect the dynamics of legislation activities in this realm.

It does not seem that a specific Spanish regulatory framework for telehealth is being developed. Nevertheless, there are some long-term projects and objectives programmed that will affect telemedicine, such as the Spanish Digital Strategy Plan to 2025, by the Ministry of Economy and Artificial Intelligence which aims to include telemedicine as a resource to improve the efficiency of the Spanish National Healthcare System.

An official report (SOU 2019:42) was presented to the government in October 2019 proposing, i.a., that all healthcare providers should provide telehealth in the form of digital healthcare visits (in addition to physical visits), and that all telehealth service providers must be able to provide physical healthcare. The report has been sent for consultation to relevant government agencies, organisations, municipalities and other stakeholders. Whether or not the report will result in a proposal for a governmental bill is yet to be seen. The report is available (in Swedish only) here.

Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the Union ("NIS2 Directive") was published in the Official Journal of the European Union on 27 December 2022. National implementing measures must be adopted by Member States and shall be applied from 18 October 2024. With effect from the latter date, the NIS2 Directive will repeal Directive (EU) 2016/1148 (commonly known as NIS1 Directive). The NIS2 Directive is a minimum harmonization directive and therefore Member States can adopt regulations that ensure a higher level of cyber security nationally.

The NIS2 Directive aims to raise the level of cybersecurity across both public and private sectors, including the health sector, and sets out inter alia required risk management measures and reporting obligations.

On an EU-level, in May 2022 the European Commission published a proposal for a Regulation on the European Health Data Space, intended to establish the European Health Data Space by providing for rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data. On 12 July 2022 the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) issued a Joint Opinion on the proposal upon request from the Commission (available here). In the Opinion, the regulators raised several concerns regarding the proposal from a data protection point of view, inter alia with regard to the proposal's wording on secondary use of health data.

Although there is currently no specific draft bill in relation to telehealth in place, the rise of COVID-19 cases in Thailand does provide a push to the regulators to issue additional guidelines as businesses in the health sector continue to thrive throughout the pandemic. Therefore, we can expect that this area will be further regulated in the near future.

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Whilst at this stage, we are not aware of any pending changes to the regulatory framework around the provision of telehealth in the UK, given that there has been an increase in the use of telehealth in the last few years, we would anticipate that regulators will continue to respond with any relevant guidance or codes of conduct (or updates to those that have already been issued), specific to the healthcare service which they regulate. This is likely to be the case in the event that any regulatory gaps are identified.

Legislation can at times fail to keep up with technological advances, and therefore it is possible that that this will become an area which is subject to further scrutiny and legislative updates in the future.

Yes, the COVID-19 pandemic accelerated more than a decade of incremental progress virtually overnight as telehealth became a critical tool in addressing the healthcare crisis. As a result of the pandemic, federal and state regulators relaxed regulations spanning multiple agencies that historically hindered the ability of healthcare providers to deliver, and patients to receive, telehealth services as first-line care.

In the wake of these regulatory flexibilities, virtual visits skyrocketed, leading to increased access to behavioral health services and strides in health equity, as telehealth and related legislation allowed for improved avenues for providing assistance to individuals requiring certain accommodations (e.g., due to disability, age, rural access, or limited English proficiency). However, the approaching end of the PHE signifies the imminent and gradual end to the flexibilities that benefitted so many.

As virtual care continues to experience widespread adoption and acceptance, regulators, legislators and industry leaders are pushing for permanent changes that would allow for continued widespread use of telehealth in the post pandemic environment. We continue to see new legislative proposals at both the federal and state levels and expect significant changes to occur over the next couple of years. While much of this change will not happen overnight, there is great demand and interest in advancing regulations to allow for continued telehealth access, both at the federal and state levels. As telehealth coverage and payment parity expand across states, we expect there to be a continued discussion with regard to telehealth reimbursement. In those states that do not require payment parity, we expect that the payment for telehealth services may decrease over time. We are closely following changes to how telehealth is regulated and reimbursed at both the federal and state level.

There is currently no specific legislation tabled for adoption. What is evidently clear is that  the current trend and aftermath of the COVID-19 global pandemic  is likely to lead to such legislation.

It is our understanding that although there are no impending policies on the horizon, the MDPCZ and the Ministry continue to monitor the administration of Telemedicine in line with the current policies in place.