{"id":2858,"date":"2018-11-05T12:05:48","date_gmt":"2018-11-05T11:05:48","guid":{"rendered":"https:\/\/www.m-q.ch\/?p=2858"},"modified":"2018-11-05T12:18:24","modified_gmt":"2018-11-05T11:18:24","slug":"recommendations-for-the-use-of-technical-standards-in-mhealth","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/en\/recommendations-for-the-use-of-technical-standards-in-mhealth\/","title":{"rendered":"Recommendations for the use of technical standards in mHealth"},"content":{"rendered":"
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The topic of interoperability is of great importance in the context of mobile health (mHealth). (Image: unsplash)<\/figcaption><\/figure>\n

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.<\/p>\n

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.<\/p>\n

The following is an initial overview of the newly established checklists and guiding values.<\/p>\n

Recommendations for mHealth <\/strong><\/p>\n

In 2018, feedback from companies in the Swiss healthcare sector was evaluated by ehealth Suisse for the first time. Under the title \u00a0\"Mobile Health and the Electronic Health Record - Recommendations for the use of technical standards and norms\".<\/a>, the recommendation was officially adopted by the Bern Steering Committee on 27 September 2018.<\/p>\n

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.<\/p>\n

Guide and checklists for the development of a safe health app<\/strong><\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

The guide also includes checklists that guide developers through key questions to be able to develop a safe and compliant medical device.<\/p>\n

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