Legal problems with platforms and portals in the medical and healthcare sector

1. liability

Depending on the design of the portal, the operator or the persons involved (e.g. doctors) may be liable in contract or in tort (e.g. under product liability law) for information, advice or services provided within the framework of such medical portals. Ultimately, the question of exactly which service is provided is decisive for the question of liability. In many areas, liability itself cannot be excluded, as exclusions of liability in terms of use are often simply ineffective vis-à-vis consumers. In particular, liability under statutory regulations such as product liability law cannot be excluded at all anyway. The design of the portal itself and the definition of the services are therefore crucial if the risk of being exposed to claims for damages as a portal operator or, for example, as a participating doctor, is to be minimized. A mere disclaimer is often not sufficient to limit liability.

Particularly in places where risks persist, good advice regarding insurance cover is important. Insurance cover should therefore also be reviewed and adjusted if necessary.

2. data protection law

In the medical field, highly sensitive health data is collected and processed. For such processing of health data, a medical platform generally requires the consent of the data subjects in accordance with Art. 9 GDPR. These declarations of consent must be drafted very carefully. Especially when doctors or other healthcare staff are involved, not only must data protection law (GDPR) be complied with, but the disclosure of data to third parties can even be relevant under criminal law, as doctors and healthcare staff are subject to medical confidentiality (Section 203 StGB). This means that not only are there fines in the event of violations, but the healthcare professionals involved also risk a criminal conviction in the event of incorrect implementation. This is precisely why data protection consents and releases from the duty of confidentiality must be drawn up carefully and in detail.

3. professional law

When integrating healthcare professions, in particular doctors, dentists, but also pharmacies, etc., the special legal requirements and professional law requirements that apply to these professions must be taken into account. In particular, medical professional law stipulates that doctors are prohibited from selling goods and other items or providing commercial services or having commercial services provided in connection with the exercise of their medical activities. Doctors are also not permitted to demand payment or other benefits for the referral of patients or examination material or for the prescription or purchase of medicines, aids or medical devices, or to promise or grant such benefits to themselves or third parties or to promise or grant such benefits themselves. In special constellations, the supply of patients in return for payment can also become relevant under criminal law as part of the new corruption offenses in the healthcare sector (Section 299 a, b StGB). Due to the threat of criminal liability for those involved, special attention is always required when examining the business model of the portal.

It should be noted here that professional law is, of course, initially binding for the healthcare professions subject to it. On the other hand, however, an indirect effect can also be considered for portals that serve as "intermediaries" for healthcare services, for example, so that the portal would also have to comply with the prohibition on referrals.

The previously absolute ban on remote treatment has now been relaxed in many cases. However, the requirements for permissible remote treatment must of course still be complied with.

4. medical device

Depending on its design, software or a web portal may even constitute a medical device. In this case, the software or portal may even require certification from a notified body.

Whether such certification is required depends on the question of whether the portal or software has a medical purpose. The clarification of this delimitation question is generally very important for the further development of the portal, as the implementation of a certification procedure entails a not inconsiderable amount of work. For example, software programs that support doctors in making medical decisions are more likely to be classified as medical devices than software that is used solely for administrative support in day-to-day practice.

5 Terms of use, general terms and conditions, revocation instructions, consumer protection law

As medical portals are usually aimed at consumers (patients) and communication takes place exclusively via distance communication media, the relevant provisions of distance selling law must be complied with. There are numerous information obligations, rights of withdrawal, requirements for general terms and conditions and terms of use that must be implemented correctly. In distance selling law alone, around 20 different requirements from various regulations in different laws must be complied with. Non-compliance can lead to costly warnings. It is therefore important to correctly integrate the terms of use and required distance selling information into the portal processes.

6 Medicines advertising law

Advertising for portals in the medical sector may fall under the Therapeutic Products Advertising Act and must then meet the strict requirements of the Therapeutic Products Advertising Act. It is true that the Therapeutic Products Advertising Act was significantly liberalized in 2012. However, certain advertising claims are still not possible and certain marketing measures, such as competitions, are excluded from the scope of the Therapeutic Products Advertising Act. Here too, non-compliance can result in warnings, which can quickly become very expensive, which is why preventive advice is strongly recommended in advance of advertising measures and advertising claims.

VOELKER has been advising companies, hospitals, doctors and other healthcare professionals on the subject of digitalization and medical portals for many years. Thanks to our interdisciplinary cooperation, we can provide you with comprehensive advice in all areas of law that are affected. You will find your contact persons opposite.