Law: New technologies, new risks | IWCMC

  • Law: New technologies, new risks

    December 13, 2020 By Evette Normand 0 comments ,  

    The introduction of new technologies in hospitals affects numerous legal aspects. This should be clarified by a team of doctors, IT specialists, lawyers, and, if necessary, ethicists.

    Almost every day, developers surprise with new products such as, gadgets, apps, software and online solutions, from data exchange via the cloud, online education and homecare monitoring to printable 3-D objects of the human body. Even some products that have not been developed for the health market are apparently ideally suited for use in hospitals or for use on or with patients.

    Various security risks

    More tech doesn’t necessarily mean better work. Security risks of various kinds are known again and again. A few examples illustrate this:

    • Measurement tolerances of lifestyle products are rarely known. They can vary even more if the damage to the devices is not necessarily visible. Values ​​obtained with these devices do not meet medical requirements and in this respect may not be assessed as such.
    • Due to a color deviation during a video consultation, the consulted doctor misinterprets the patient’s color.
    • Commercially available materials for use in 3-D printers may contain allergens and toxins or may not have the expected resilience.
    • A webcam integrated for patient observation has a security hole that opens a gateway from the outside into the clinic’s EDP.
    • A Wi-Fi access point not approved by IT interferes with the use of medical devices.
    • A cloud server used for communication with patients and the exchange of findings is located in a third country without the data protection requirements within the meaning of the GDPR being met. The cloud server also has security gaps that allow third parties to access patient data.
    • At the same time, a new documentation system with time recording makes it possible to analyze the work of the individual employees individually.

    Numerous legal requirements

    There are numerous legal aspects to consider. For example, a doctor owes the generally recognized professional standard that existed at the time of treatment. If he deviates from this without prior agreement, this can result in malpractice. Lifestyle products do not meet this standard because they do not meet the requirements of a medical device. Doctors must always evaluate medical data that they or third parties have collected from devices other than verified and familiar medical devices with the necessary care. Under no circumstances should they accept values ​​as certain.

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