Patient safety
patients might refuse consent for their personal data to be seen by anyone outside the clinical sphere.
It’s a legitimate concern which can stand
in the way of the open exchange of registry information with manufacturers. Even with strict privacy laws in place and protocols around anonymising data, there is a fear that data breaches could result in a loss of trust, legal consequences and reputational damage. On a practical level, data sharing is a complex
process. Medical registries often collect data in different formats and systems, according to different standards. If these are incompatible, it could be difficult for a manufacturer to access and interpret the data. There is also a risk that some data may be incomplete or inconsistent, making it unreliable or difficult to use. There are commercial concerns too. MedTech is a competitive industry,8
and it
goes against the grain for a manufacturer to share data on device performance, adverse events or patient outcomes which might give their competitors an advantage. There is also the risk of exposing intellectual property to competitor organisations. The prospect of information about performance of a new design of pacemaker or biosensor being shared with competitors could make manufacturers more wary of launching new-to-market devices. Ultimately, without a culture of innovation, it will be the patients who suffer. While there are understandable concerns about sharing registry data with the MedTech industry, the benefits of unlocking valuable clinical insight are too important to ignore.
And with the new post-market surveillance regulations in place, it’s becoming increasingly urgent to find secure and effective ways to provide medical device manufacturers with the information they need to ensure the safety of their products.
An effective model for data sharing The positive news is that we’re seeing the development of more secure and collaborative approaches registries can use to share data with MedTech manufacturers, which mitigate the risks, and make data sharing a much more viable proposition. One example of this is the health data partnership,9
which draws up agreements
between data controllers, which may include registries and manufacturers for a more seamless way to share anonymised clinical data securely. A partnership model builds stronger relationships between all the stakeholders – hospitals, patients and manufacturers – so that data can be shared more effectively. Medical data can be incredibly powerful, but as it relates to individuals and their health conditions, medical data is also highly sensitive.10
To protect confidential patient
data, or commercially sensitive data, a health data partnership can draw up secure data management policies, and act as an interface between a data controller and a manufacturer. This includes defining what data is shared, how data is anonymised, and the appropriate format for reporting data and providing access to it. Having secure data policies helps to
overcome registry and patient concerns about protecting confidential personal data, while also reassuring manufacturers that commercially sensitive data can only be accessed by the other partners in the agreement.
A health data partnership can also simplify the very complex legal processes involved in sharing medical data. The partnership manages all the necessary contractual relationships to provide a one stop shop for the manufacturer. This takes the contracting challenges out of the equation. It also removes sources of possible conflict because all parties have agreed how the data will be accessed and used. With new, tighter regulations on medical
devices coming into force, a partnership model can support manufacturers’ regulatory submissions, and smooth the path for approvals from regulatory bodies for new and existing products.
By simplifying and securing the way data is
shared, a health data partnership can remove the barriers to data sharing for data controllers, and allows manufacturers the opportunity for better quality, clearly reported data which can be turned into useful insight.
Better insight for the MedTech industry While manufacturers can collect their own data on device performance for the regulators, this can prove time-consuming and expensive, requiring complex IT and research structures. There is always a risk with manufacturers collecting their own data, that unintended bias could affect the data quality. Having a data sharing partnership with independent health registries can simplify the process for the medical device industry as they already have the IT mechanisms to capture large scale, objective data on medical devices and treatments. The NJR,11
for example, has
more than four million records on orthopaedic implants carried out since 2003. Registries can also provide accurate information for manufacturers, because they collect the data on devices at the point of use. If a surgeon scans a code on a shoulder joint at the time of a surgical procedure, the data goes straight into the system, enabling the performance of that joint to be tracked in the future. The MedTech industry gains a more complete
picture of the patients who are using or receiving their products where additional data residing in a hospital system, such as MRI scans, test results or medication history can be augmented with registry data. An effective partnership model also benefits from expert opinion from clinicians, such as radiologists’
November 2025 I
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