These healthcare apps are great examples of mHealth, or ‘Mobile Health’. mHealth is a sub-category of eHealth (or ‘Electronic Health’) that focuses on smartphones. The British ORCHA stated in their ‘mHealth 2030’ rapport‘ report that they expect these applications to have a proven cost-effective impact on healthcare over the next 10 years, to make high-quality care more accessible and to make the prescription of mHealth applications as normal as the prescription of traditional care/medication.
Medical devices
According to Article 2, section 1 of Regulation (EU) 2017/745, the purposes of a medical device are:
Diagnosis
Identifying a disease from symptoms.
Prevention
Preventing or limiting damage to health.
Monitoring
The collection of data regarding health.
Treatment
Medical actions aimed at recovery.
Prognosis
Prediction of the future state of an illness.
Relief
Prevent and treat physical pain or other problems.
Diagnosis
Identifying a disease from symptoms.
Prevention
Preventing or limiting damage to health.
Monitoring
The collection of data regarding health.
Treatment
Medical actions aimed at recovery.
Prognosis
Prediction of the future state of an illness.
Relief
Prevent and treat physical pain or other problems.
Data Security
Healthcare apps often require the processing of confidential (patient) data. Therefore the security of these types of applications is crucial. This is why the Dutch Standard (NEN) 7510 was created. This standard includes determining, establishing and maintaining measures to secure the provision of information for healthcare institutions.
In addition, the ISO/IEC 27001 standard includes establishing, implementing, executing, monitoring, assessing, maintaining and improving a documented Information Security Management System, in order to ensure the security of data as well.
everywhereIM is certified in both of these standards. Hence, your data is in safe hands. You can find our certificates on our ISO/NEN page.
CE-markings
Medical devices (such as healthcare apps) that appear on the market and are traded within the European Union (EU) must comply with European rules and legislation. In doing so, it is mandatory that these devices have a CE-marking. As of May 26, 2021, new regulations have come into effect (Medical Devices Directive) that bring a number of important changes for healthcare apps.
Whereas previously healthcare apps were often not yet considered medical devices and therefore did not have to comply with the corresponding regulations, the definition of a medical device has been adjusted in such a way that healthcare apps will now fall under that definition sooner. everywhereIM already has provided more than 50 healthcare apps with a CE-file and submitted them to Farmatec/IGJ.
Want to know if your healthcare app falls under the medical device definition and which procedure you should follow? Then visit the CE-marking website.
Healthcare apps by everywhereIM
Below are some of these types of apps developed by everywhereIM. All of these apps were developed by specialized developers and medical consultants.
The Antibiotics App:
The Antibiotics App provides advice for therapy and prophylaxis of common infectious disease conditions and the main properties of all antimicrobial agents.
NVAB guidelines:
To date, this app from the Dutch Association for Occupational Medicine (NVAB) consists of 5 evidence-based guidelines. The NVAB aims to improve the implementation of the guidelines by offering this medical app.
migraineAPP:
The migraineAPP has been developed for people with migraine. By keeping a diary, they can get a better grip on their migraines.
Gotit?:
This app is for anyone looking for information about a (possible) STD and its treatment.
