Fråga: Launching a digital wellness guide
Hi! We will launch a digital wellness course and we are trying to understand what we need in terms of disclaimers, consent, etc. (such as for instance "we do not replace your doctor"). We are positioning ourselves as a wellness guide, as opposed to a health service, and we need to make this clear. Could you please help us understand: 1) what are the disclaimers/consent/etc we need 2) where we need them (e.g. once when signing up, or throughout the programme) 3) anything else relevant in terms of regulatory / legal Thank you for your help!
Legalbuddy svarar

Thank you for reaching out to us at LegalBuddy. It can be tricky to navigate the legal landscape for digital wellness platforms. When digital platforms create new ways of organizing activities it can make it difficult to determine who is responsible for providing care and therefore also is responsible for patient safety.

Firstly it is important to define what category your business falls into. The Swedish Health and Medical Services Act defines health care as “measures for the medical prevention, investigation and treatment of diseases and injuries, the transport of patients and the care of the deceased”. This definition is very broad and in order to find out if your platform provides health care, the starting point is the user perspective. Does the user have to make an account, identify themselves or pay for the service? If anyone can take part on your platform without having to do anything, it is most likely not defined as health care but rather information or advice. If your platform provides the possibility to make an appointment with a medical expert to find out a cause for a medical issue, it is included in the definition of health care.

The reason why it is important to determine if your business falls into the legal defintion of health care is that only a limited category of people is able to work within health care. These health care professionals have responsibility to work in accordance with science and best practice. Sometimes the line between providing health care and just giving advice can be very fine since a health care professional can be perceived as providing health care even if it would not be considered health care if a non-medical staff would give the same advice.

If you fall into the health care definition you are seen as a healthcare provider. This means that you are under the supervision of the Swedish Inspectorate for Health and Social Care (IVO). You must then register as a health care provider at IVO and you have to comply with a far-reaching responsibility. This responsibility includes complying with specific health care regulations and rules issued by the National Board of Health and Welfare.

If you have concluded that it is health care you are providing, the next step is to determine who the actual healthcare provider is. There are certain healthcare platforms and apps that only bring together providers with patients and in those cases the platform is to be regarded as an intermediary. The actual health care professionals themselves, not the platform, are then the ones who have to comply with the far-reaching regulations. To determine if you are a provider or a sharing platform is an assessment that depends on several factors and have to be made on a case-by-case basis.

As mentioned above, the starting point for the assessment is the user perspective. Therefore it is very important to clearly communicate what your wellness course actually is, the terms and conditions as well as its limitations. This can be done in several ways, but it is recommended to have the information available before the user has to sign up for the course.

To answer your last question about other relevant legal aspects, it is important to have a strong GDPR strategy. This is especially important if you are dealing with sensitive data such as health care and patient data.

Hopefully this answer was helpful to you. I recommend you to book a meeting with us in order to analyze and discuss what is best to do in your case. We also encourage you to send in more questions to LegalBuddy and wish you best of luck with your business launch. 

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