{"id":350316,"date":"2023-11-16T04:29:42","date_gmt":"2023-11-16T09:29:42","guid":{"rendered":"https:\/\/platohealth.ai\/bfarm-guidance-on-fast-track-process-for-digital-health-applications-data-security-regdesk\/"},"modified":"2023-11-21T12:41:58","modified_gmt":"2023-11-21T17:41:58","slug":"bfarm-guidance-on-fast-track-process-for-digital-health-applications-data-security-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/bfarm-guidance-on-fast-track-process-for-digital-health-applications-data-security-regdesk\/","title":{"rendered":"BfArM Guidance on Fast-Track Process for Digital Health Applications: Data Security | RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The new article addresses the aspects related to the data security measures to be introduced by the parties involved in operations with digital health products. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n

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The German regulating authority in the sphere of healthcare products (BfArM<\/a>) has published a guidance document dedicated to the regulatory status of digital health applications (DiGA).<\/p>\n

The document provides an overview of the respective regulatory requirements based on the existing legal framework and also highlights the key points to be taken into consideration by medical device manufacturers (software developers) and other parties involved to ensure compliance thereto.<\/span><\/p>\n

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. <\/span>
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<\/span>The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Data Security: Key Points<\/b><\/span><\/h2>\n

First of all, the authority emphasizes the importance of data security, focusing on the protection of confidentiality, integrity, and availability of data processed via a DiGA. <\/span>
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<\/span>The DiGAV (Digital Health Applications Ordinance) categorizes data security requirements into two:<\/span><\/p>\n