During the coronavirus (COVID-19) pandemic, we have seen a dramatic shift from in-person visits to telehealth services around the globe, unveiling what may be the new normal for providing healthcare services.
Regions around the world have quickly adapted to providing telehealth services as a means to prevent possible exposure to COVID-19 and allow for critical patients to get the in-person care they need. As the world begins the shift into a post-pandemic period, regions continue to develop and advance their telehealth service capabilities, with some global trends emerging. However, countries have approached the expansion in diverse ways, leading to a complex legal and regulatory landscape.
The United States has historically been a leader in the development and implementation of telehealth technologies. This effort has been led in large part by states and commercial enterprises, but since the COVID-19 pandemic, the federal government has significantly revised its policies to promote and prioritize telehealth technologies. These policies have included a massive increase in the number of patients eligible to obtain services via telehealth and reimbursement support to incentivize healthcare providers.
In the United States, the delivery of healthcare services is largely governed by state law and enforced through state licensing boards. As a result, states are important players in determining what types of telehealth technology are permissible and the scope of an individual’s medical practice. In addition, although telehealth services have long been a cash-only (noninsurance) business, private insurance companies and state Medicaid programs are increasingly providing reimbursement opportunities for telehealth. These opportunities, at least prior to the COVID-19 pandemic, have not been viewed as sufficient to support the widespread adoption of telehealth.
Telehealth industry stakeholders frequently advance two major concerns about the current legal and regulatory environment: difficulty in obtaining licensure and low reimbursement rates. Because each state separately licenses healthcare providers to furnish services to citizens located in that state, a telehealth provider could potentially need to obtain 50 licenses if the telehealth services were offered in each state. Moreover, although states are revising their insurance policies to promote coverage of telehealth services through the passage of “payment parity” laws, many telehealth providers find it difficult to obtain adequate reimbursement rates for their services. However, the reliance on telehealth services as a result of COVID-19 and the resulting regulatory and payment changes suggest that this practice modality will become mainstream.
Internet-based medicine has no doubt played an important role in China’s fight against the COVID-19 pandemic for the last several months. With the support of a series of regulations by the People’s Republic of China (PRC) National Health Commission (NHC), many hospitals as well as medtech companies in China have developed and launched virtual platforms offering online consultation, triage, drug delivery etc. services so as to connect doctors and patients remotely to reduce the risks of further spread of the virus.
Under current PRC law, telemedicine has a relatively limited application, which refers to collaborations between medical institutions, either through direct coordination or through virtual healthcare matching platforms. On the other hand, internet-based medicine is a more general concept that covers various types of medical activities supported by the internet and other information technologies.
The NHC released the Opinions of the General Office of the State Council on Promoting the Development of “Internet + Healthcare” and three other supporting regulations in 2018, which have been considered to form the basic framework of China’s internet-based medical activities and telemedicine systems. Note that, however, China’s internet-based medicine under the existing legal framework still relies on physical medical institutions in mainland China, and PRC laws have not yet developed a specific regime regulating internet-based cross-border medical activities provided by foreign medical institutions from overseas to Chinese domestic patients.
Telehealth is a rapidly emerging sector in Germany driven by economic and political factors. While established players from the healthcare sector as well as numerous startups develop and provide respective applications and services, the German legislator has enacted first legal acts as a legal framework:
- In 2016, the Secure Digital Communication and Healthcare Applications Act (Gesetz für sichere Kommunikation und Anwendung im Gesundheitswesen) entered into force providing for the obligation of the statutory health insurers (Gesetzliche Krankenkassen), hospitals, physicists, and pharmacies to create and implement the basic conditions for a telehealth infrastructure. Such telehealth infrastructure ultimately aims at effectively connecting experts in the healthcare sector to enhance the treatment of patients including, for example, the provision of online diagnosis through live video chat, electronically available patient records, and a digital master data management (Digitales Stammdatenverzeichnis) operated by health insurers.
- In 2018, the delegates of the German Medical Association (Deutscher Ärztetag) agreed on an amendment of the then-applicable Code of Conduct for the Medical Profession (Ärztliches Standesrecht) generally enabling qualified physicians to diagnose patients remotely including through live video chat.
- In 2019, the Digital Supply Act (Digitale-Versorgung-Gesetz) provided for further legal amendments to promote telehealth applications. These measures, for example, exempt remote treatments from the general advertising restrictions in the German healthcare sector. The Digital Supply Act further implemented rules with respect to the coverage of costs associated with digital applications related to the telehealth infrastructure by German statutory health insurers under certain conditions.
The COVID-19 pandemic has further accelerated the developments in the telehealth sector. The German federal government commissioned a voluntary, privacy-friendly COVID-19 warning and tracking app for smartphones that has been downloaded more than 16 million times since its launch in June 2020, thanks to an endorsement from the German federal government. The app serves as a role model for other countries. In addition, the German federal government issued a financial stimulus package which, among others, includes a €3 billion investment package to strategically expand the digital and telehealth infrastructure in German healthcare.
Singapore’s telehealth sector is driven by the growing telemedicine industry, which has seen an increase in available digital self-help options to consult a medical doctor through online web-based applications. Telehealth providers in Singapore are mainly focused on providing remote telemedicine and/or on-demand house call services.
To date, there are no specific regulations governing the telemedicine sector. However, in January 2020 Singapore’s Ministry of Health (MOH) announced the sector would be licensed in the upcoming Healthcare Services Act by the end of 2022. In contrast, telehealth providers developing or importing electronic and telecommunications technologies are to comply with the regulatory guidelines issued by Singapore’s Health Sciences Authority and the Health Products Act.
To better understand the operating environment and challenges of the growing telemedicine industry, MOH had collaborated with prominent telemedicine service providers to launch a regulatory sandbox in 2018. As this is an emerging industry in Singapore, there are some unique challenges faced by telemedicine service providers: (1) ensuring its medical doctors are qualified to provide medical advice in Singapore; (2) the risk of ethical code breaches by medical doctors in providing telemedicine care; (3) uncertainty regarding legal liability in respect of medical malpractice or negligence; and (4) data privacy issues under the Personal Data Protection Act 2012.
UNITED ARAB EMIRATES (UAE)
As a regional leader in innovation, the UAE was an early adopter of telehealth. The Dubai Health Authority introduced regulations in 2018 to address the increasing demand for services. The UAE has focused its regulation around six key areas:
- Telemonitoring (remote patient monitoring)
- Mhealth (mobile health)
- Telerobotics and robot-assisted services
The UAE has recently seen a shift in prioritizing the use of technology to provide healthcare services to its residents. Building on the already existing regulatory framework, the UAE used the COVID-19 pandemic as a catalyst to ramp up the various technologies being used in the medical industry. The UAE Department of Health, for example, recently introduced an app that will help track COVID-19 cases in the UAE.
Various UAE-based medical institutions have recently implemented or increased their telehealth consultation services arising from the COVID-19 pandemic. The majority of hospitals and healthcare institutions had in fact already rolled out the option to replace face-to-face consultations with telephone interaction, in order to minimize contact between patients and healthcare providers.
While the provision of telehealth services is regulated in the UAE and its key players are keeping up with market needs, health insurance companies are working on facilitating the coverage of such services.