Recommendations for the use of technical standards in mHealth
On 1 November 2018, eHealth Suisse adopted recommendations on technical standards and norms. At present, there is no uniform definition to guide the owners or users of the electronic patient dossier (abbreviation: EPD) to store their health data on mobile devices such as apps and to use them "correctly".
The "Recommendations for the use of technical standards" in the mHealth area were recently published. Even if the implementation effort required to be able to enter personal data into the EPD now seems less complex, not all important aspects of the use of so-called eHealth apps have yet been regulated or standardised.
In summer 2018, twenty organisations had submitted their comments in a public hearing. Also, more and more Swiss healthcare organizations are participating in test series called "Projectathon", see the focus articles in the current Management & Quality (issue 2018/11). At the beginning of November, the recommendations on the use of eHealth data for mobile devices were published.
The following is an initial overview of the newly established checklists and guiding values.
Recommendations for mHealth
In 2018, feedback from companies in the Swiss healthcare sector was evaluated by ehealth Suisse for the first time. Under the title "Mobile Health and the Electronic Health Record - Recommendations for the use of technical standards and norms"., the recommendation was officially adopted by the Bern Steering Committee on 27 September 2018.
To make this possible, the mHealth working group has adopted recommendations for technical standards and norms that allow mHealth apps to be integrated into the EPD. On the one hand, the recommendation report contains an overview of existing technical standards and norms for the area of mHealth and, on the other hand, derives recommendations from them for the attention of app developers.
Guide and checklists for the development of a safe health app
Because the population records health data or vital signs with different mobile devices or applications and "should" be able to enter them in the form of documents into the electronic patient dossier (EPD), there is now guidance.
The mHealth working group has commissioned the company ISS AG to implement the recommendation for action on the topic of medical devices from the recommendation document "mHealth - Recommendations I". When designing a health app, developers must ask themselves at an early stage whether their product is a medical device and which regulations they must comply with.
To support developers in this process, ISS AG has developed a guideline. This guide provides practical assistance in distinguishing between lifestyle / wellness products and medical devices and for the preparation and implementation of the certification process as a medical device.
The guide also includes checklists that guide developers through key questions to be able to develop a safe and compliant medical device.
Legal opinion on data protection
As an implementation of the recommendation for action on the topic of data protection and information security from the recommendation document "mHealth - Recommendations I", the mHealth working group commissioned the law firm Walder Wyss AG with a legal opinion.
This report examines the legal situation regarding mHealth in the EU and the USA and shows where there is still a need for adaptation in Swiss law. It formulates recommendations and serves as a basis for future legal activities of the Confederation and the cantons in the area of mHealth.
eHealth + mobile = mHealth
"mHealth" is a particular aspect of the digitalisation of healthcare: it describes the technical requirements for using health-related data from mobile medical devices and from so-called "wearables" (e.g. fitness wristbands) also for the electronic patient record (EPD).
However, the topic of "mHealth" is currently very much driven by providers and consumers, and a coordinated approach is still lacking in Switzerland.
eHealth Suisse is therefore developing the basis for coordinated processing and has drawn up initial recommendations. The document contains recommendations for action in the area of "Mobile Health", whereby above all the transparency of the applications offered on the market is to be improved. In addition, the paper addresses the use of mobile data in the context of the electronic patient dossier.
You can find more details under
"mobile Health (mHealth) - Recommendations I; Initial situation and first steps"
of eHealth Suisse.
