E-health

At the Danish Patient Safety Authority, we advise patients to think it over carefully before using the many web-based tools and apps within e-health services. Take good care of your health – on the internet as well.

The internet has plenty of tools to help you reach health goals through so-called e-health services (informative web pages, apps to track your health as well as telemedicine, etc.), and they are used by both healthcare professionals and patients. The use of these e-health services has grown considerably in recent years.

The professional segment of the e-health industry is in many ways valuable to patients as well as society – scientifically and health-wise (closer monitoring, greater and faster knowledge sharing, etc.) and economically. For example, some patients can avoid taking time off work for GP appointments, and more patients can be treated faster.

Nonetheless, the Danish Patient Safety Authority sees a need to watch out for the more unprofessional segment of the industry whose quality of apps and web pages could seriously jeopardise the safety of patients. In Denmark, it is mandatory for doctors to verify the identity of patients before initiating treatment. We have seen many examples of foreign websites that sell medicines without proper verification of the consumer's identity and thus the patient's name and health condition.

In Denmark, the Danish Patient Safety Authority can monitor e-health services that are managed by healthcare professionals with a Danish authorisation or Danish healthcare organisations. For example, the following rules apply to the responsibilities, etc. related to doctors' use of telemedicine (page is in Danish only). But the Danish Patient Safety Authority has no authority to monitor web pages, apps and similar services that are managed outside Denmark and which may, or may not, be approved by a notified body (private company authorised by national authorities to approve apps for CE marking).

It means that Danish patients can use websites and apps that may have been approved by other countries and may basically be serviced by foreign staff. In such cases, the Danish Patient Safety Authority has no possibility to intervene directly, and therefore patients cannot complain or receive compensation. The Danish Patient Safety Authority can, however, approach the country from which any such web page or app is controlled to highlight any significant patient-related problems that have come to its knowledge.

We advise patients to be aware of the following:

• Web pages and apps do not hold all details about your health. The diagnosis or treatment that you are offered through an e-health service could influence any other treatment that you currently receive.
• It is advisable to tell your GP or healthcare professional if you have bought services from a website or an app so this can be taken into account in your own treatment if necessary.
• Whether sufficient data privacy is provided for data submitted by patients to the website or app and for data submitted to patients.
• Whether the website or app is safe on the whole.

The Danish Medicines Agency also offers good advice to citizens when buying medicines online. Here, it is particularly important to look for the green EU logo to see if the website is operating legally.

The Danish Medicines Agency has also issued guidance for consumers to find out when a health app is considered to be a medical device. If a health app is a medical device, it will bear the CE mark. The CE mark is valid throughout the EU.

It is important that we have supervisory focus on e-health because:

• Healthcare and treatment of disease must also be safe when e-health services are used.
• Healthcare and treatment of disease are becoming more and more dependent on e-health, which is growing rapidly as a result – and therefore, there should be greater awareness of the risks.
• Moving forward, patients will gain far greater control of their own health via e-health programmes.