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Manufacturing Technology Insights | Monday, August 03, 2020
All manufacturers developing medical devices in the EU are required to adhere to the GDPR and not adhering will result in heavy financial penalties.
FREMONT, CA: The enforcement of the European Union (EU) General Data Protection Regulation (GDPR) is about to impact medical device manufacturers. The new GDPR requirements will influence medical device manufacturing by enhancing privacy and security for EU citizens. Regardless of the organisation's location, the regulations apply to any organisation collecting personal private data from individuals in the EU.
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[vendor_logo_first]While most of the GDPR can affect the back end of medical device data handling, some of the GDPR affects medical device manufacturing itself. Consent is the first concern for a manufacturer while manufacturing a medical device that will access confidential patient data. If the patient is interacting with the medical device, a consent form must be provided to patients, enabling them to acknowledge their rights and consent to the processing of their information. The basic concept with GDPR is that the patient's data is no longer available to process at will. Instead, the device must be configured to safeguard patients' data. Violation of this concept can be grounds for hefty penalties.
The GDPR will also require privacy by design at work and achieve the level of state of the art in security, which needs to be a level appropriate to the risk involved with the data processing. The GDPR will require the same with regard to security. This means privacy by design at work and achieve the level of state of the art in security, which also needs to be a level appropriate to the risk involved with the data processing.
In general, GDPR changes the way in which medical device manufacturing enterprises must take into consideration the design of medical devices with respect to communication, software updating, data storage and processing. While GDPR may initially seem overwhelming, organisations employing comprehensive user privacy practices will be well on their way to regulation adherence and data protection.
See Also: Top GDPR Solution Companies in Europe
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