As the European Commission recently described in its Green Paper: mobile health, also called mHealth, has great potential. It allows you as a consumer to assess your own health status indicators, e.g. by measuring your heart rate through a skin sensor and your mobile phone. Interpreting the figures you get can be tough and, therefore, when your phone warns you about abnormal patterns, it should advise you to consult your physician as well.
A medical software product with such functionality has obvious benefits. It avoids unneccessary visits to the doctor and it also monitors your vital signs on a continuous basis. But it raises potential risks at the same time. This is where European legislation comes in.
When a producer/developer marks a device with the CE marking, this denotes that the manufacturer complies with all the rules. For example that he qualifies the product as a medical device. This means that the manufacturer has described and documented, among other essential requirements, possible risks of using the product. It also tells you that the product has been thoroughly assessed as being safe when used at the intended purpose.
The Dutch Health Care Inspectorate (DHCI) is the competent authority of the Netherlands and is part of the Dutch Ministry of Health, Welfare and Sport. As an inspector at the DHCI,my duty is to check whether manufacturers comply with current legislation and whether the documented procedures meet the legal requirements. My role is to make sure you can use mHealth products placed on the market in a safe way.
"It is important that, apart from the manufacturers, you as a consumer play a role in product safety as well."
In the Netherlands,there are several successful initiatives which enable healthcare professionals and consumers to share their experiences with mHealth products. For example, the website of the Royal Dutch Medical Association (KNMG) for health care providers and the website of the Federation of Patients and Consumer Organisations in the Netherlands (NPCF). Usability tests are also available online so everybody can check how the product works. In fact, it is important that, apart from the manufacturers, consumers play a role in product safety as well. You should be aware of possible risks when using mHealth products, as described by the manufacturer.
For example an unexpected inferior connection between the skin sensor and your phone might result in unreliable output. You are then strongly encouraged to report product malfunctions to the manufacturer. It always gives him useful feedbacks to improve the device and minimise health risks or misuse. This nurtured dialogue between consumers, physicians and manufacturers is key to ensure that new technologies such as mHealth products are used in a safe way and help improve healthcare.
Stefan Visscher is inspector at the Dutch Health Care Inspectorate (DHCI). The DHCI is the competent authority of the Netherlands for medical devices and is part of the Dutch Ministry of Health, Welfare and Sport.