Legal Alerts / 18 Sep 2014

Legal Alert – Health Applications and Exercise Gadgets – Are They Medical Devices?

Is your company planning to launch a health application or a tracker designed to monitor user’s health, fitness or exercise habits in Finland?  In most cases the data which these gadgets gather benefits only the fitness enthusiastic consumer, but the information may also be shared with a doctor for diagnostic purposes. This is why it is beneficial to consider beforehand whether your application/device falls under the definition of a “Medical Device” or is considered merely to be smart fitness equipment?

What is a medical device?

Medical device has a wide legal definition. It means an instrument, equipment, tool, software, material or other device or accessory used alone or in combination, which the manufacturer has intended to be used for human beings a) for diagnosis, prevention, monitoring, treatment or alleviation of a disease; b) for diagnosis, prevention, monitoring, treatment or alleviation of an injury or a disability or for compensation of one; c) for investigation, replacement or modification of the anatomy or a physiological process;  or d) for control of conception (Section 5 of the Finnish Medical Devices Act).

In the assessment of medical devices carried out by the National Supervisory Authority for Welfare and Health, Valvira MEDDEV guidelines drafted by the European Commission play a significant role. In this respect relevant factors include: Whether or not the manufacturer has intended the device to have a medical purpose identified in the label, the instruction for use and the promotional material related to the device. In addition, stand-alone software is considered to be a medical device, if the software performs an action on data which benefits individual patients and which is performed for one of the legal medicinal purposes and is different from storage, archival lossless compression, communication or simple search. Other case-by-case circumstances may also have significance.

Key issues to consider: 

1. What are the functions /purpose of your applications, and do they benefit individual patients?
2. How is the purpose described to the consumers?
3. Are there strong enough disclaimers to exclude the medical use of the device?
 

Classification brings along legal obligation

If your health application is defined as a medical device, it shall comply with the legal obligations set out in the Finnish Medical Devices Act, including fulfilling the applicable essential requirements and applying for the CE-marking. Obligations are also set on classification, marketing, instructing and monitoring of the use of the device, among others. 

Does your application process personal health data?

One should also consider how the data is processed by the application/device. Is the data gathered into the company’s server or is it shared with other users or interested parties in a cloud? In particular, in situations where the gathered data is of personal, sensitive or otherwise critical nature, the responsibilities under the data protection legislation should be taken under scrutiny of the company.
In case you have any questions or need any help with the above-mentioned assessment regarding both medical devices and data protection, we are more than happy to be of assistance. Please do not hesitate to contact us.

Additional information

Hannu Järvinen
Tuija Metsävainio
 

Share on LinkedInTweet about this on TwitterShare on Facebook