#National data guardian data security standards free#The NHS is the public healthcare system free at the point of use in England (with similar systems across Wales, Scotland and Northern Ireland), and is one of the largest single payer healthcare systems in the world. This will be the baseline and starting point for organisations before they look to contract with the NHS (a more detailed look at GDPR compliance in the life sciences sector is available here). Given the sensitive nature of the personal data in the medical device sector, it's important that data protection compliance is prioritised. These laws set out principles that must be adhered to when processing personal data and special requirements for the handling of sensitive, 'special category' data, including medical data. The Data Protection Act 2018 (DPA18) is the overarching statute, incorporating the EU’s General Data Protection Regulation into national law as the UK GDPR, from the end of the Brexit transition period (1 January 2021). When processing any personal data in the UK, targeting products and services to people in the UK or monitoring their behaviour in the UK, organisations must adhere to the UK’s general privacy regime. Here, we consider the most compelling standards any company must meet to become an NHS supplier with access to NHS patient personal data. As such, medical device companies that are looking to sell in the UK are unlikely to make much of an impact in the market unless they can meet NHS requirements. The supply and use of medical devices fall well within the scope of data protection legislation, but in the UK they are also subject to an increasingly complex and sophisticated data framework specific to the UK healthcare regime.Īlthough the National Health Service doesn't have a complete monopoly on the provision of healthcare in the UK, it's the biggest player and purchaser by a huge margin. The rapid evolution of medical devices and their ever growing connectivity means that they not only generate large amounts of personal data but they are increasingly capable of sharing the data both deliberately and (potentially if hacked) without the consent of the patient or the data controller.
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