BioTalk is a news hub brought to you by Bird & Bird's International Life Sciences & Healthcare Group. Read more about us >

Hungary: New Legal Provisions set out Mandatory Infrastructure for Telemedicine

Healthcare 4 min
September 29, 2020

Until recently the Hungarian legal background of telemedicine was not particularly detailed. For obvious reasons COVID-19 increased the demand for eHealth services. As a result, now the rules on minimum professional requirements for providing health services specifically include instruments and infrastructure necessary for telemedicine, such as mobile devices, medical devices and sufficient access to internet. The responsibility for data security, creating adequate procedural rules, and patient identification that comes with the use of such means and devices falls on the health service providers.

In Hungary Decree No 60/2003 of the Minister of Health (“Decree”) sets out the minimum professional requirements for providing health services. The addressee of these obligations is the health service provider, irrespective of being private or publicly owned.  Such requirements include necessities such as adequate room for patient consultation and examination; storage of medical instruments and files; waiting rooms and bathrooms etc.

With COVID-19 the need for telemedicine was pressing and developments in the field of eHealth have accelerated. Responding to this need, the Hungarian Government adopted specific legal rules earlier this year[1] for telemedicine services. These covered a wide range of long-distance services such as patient and clinician contact, care, advice, reminders, intervention, monitoring, and remote admissions. However, these rules were only in effect during the state of emergency, which was later lifted on 8 June 2020.

The new amendments[2] to the Decree effective of 17 September 2020 provide a permanent framework for providing telemedicine with the basic minimum infrastructural requirements. The outcome of this is that now not only is it a desirable possibility to provide health services to patients via electronic means and telecommunication technologies, but the legal landscape provides for it with setting out certain obligations in this field, backed up with fiscal support.

What services qualify as telemedicine services?

According to the Decree, telemedicine services are defined as: (i) specific health services that can be provided without personal consultation; as well as (ii) the sharing of health data via telecommunication means, according to the Act on the Protection of Health Data – in both cases if professional considerations allow. These are the following:

  1. setting up diagnosis and therapeutic advice;
  2. consultation;
  3. issuing medical admissions for further examinations;
  4. patient management tasks;
  5. care services;
  6. providing therapy and rehabilitation; and
  7. prescribing medicaments and medical devices.

What are the mandatory obligations for health service providers?

The recent amendment aims to make the obligations clear when providing telemedicine services.

This means that:

  1. Health service providers must procure the necessary telecommunication devices, medical devices and specific devices for health services requiring a video connection by law.
  2. They must set out and provide the procedural rules and patient information sheet for the use of telemedicine services. For services conducted via video calls, the responsibility of patient identification falls on the health service providers.
  3. Where the telemedicine services are conducted using an internet connection, stable and secure connection must be provided, including data security, antivirus and malware protection.

The costs of complying with these obligations and offering telemedicine can now be accounted against the State Health Insurance fund by using the new set of fiscal codes for both such instruments and telemedicine services.

Takeaways

These amendments now make it possible for health service providers to provide certain services as telemedicine, and to actively procure and create infrastructure for it. The fact that this expenditure is accountable against state funds also supports developments in this area. These changes are expected to lead to lively competition and an increase in eHealth and telemedicine platforms.

Understandably, these possibilities come with the responsibility for creating a safe and more importantly compliant environment for such services, ensuring that the safety of both the patient and their data is not compromised. This also prompts developers of telemedicine platforms to more closely observe and comply with the Hungarian regulatory framework.

[1] Decree No. 157/2020. (IV. 29.) of the Government

[2] Decree No. 33/2020 (IX.16.) of the Ministry of Human Resources

Written by
Bettina Kovecses
Bettina Kovecses
I am a senior associate in the Intellectual Property Group, based in the Budapest office. I also lead the Hungarian retail and consumer team.

Related articles

Managing Scientific Collaboration Agreements within the French Healthtech Sector
Scientific Collaboration Agreements allow a public servant, most of the time a researcher, (who...
Manufacturing and stockpiling waiver set to limit rights of holders of SPCs for medicines
On 17 April 2019, the European Parliament approved, by a large majority, an amendment of the Regulation...
Telemedicine in France: state of play
Telemedicine is governed by Article L6316-1 and R6316-1 and seq of the French public health code...
Cookie consent
We use analytics cookies to help us understand if our website is working well and to learn what content is most useful to visitors. We also use some cookies which are essential to make our website work. You can accept or reject our analytic cookies (including the collection of associated data) and change your mind at any time. Find out more in our Cookie Notice.