Health Data: Opportunities and legal constraints

The growing availability of data in the healthcare sector has opened a fresh frontier in the industry, generating numerous potential opportunities. Combining modern biomedical investigations with potential new insights derived from large-scale analysis of health data offers the chance to create new products, services and therapies. It encourages innovation and has the potential to improve treatment protocols.

However, realising these opportunities requires overcoming significant challenges, many of which relate to the transfer and sharing of such highly sensitive information. There is a complex legal framework surrounding the processes for dealing with data handling and data security. The unlawful use of personal data, and breaches of protocols and security, can carry heavy financial penalties or even an order to cease the use of the data in question.

PwC Legal will help you in navigating this challenging legal landscape, informing you where the liabilities lie, what is and what is not possible, protecting and advising you from a legal perspective. Our expertise will help place you in the best possible position to take advantage of the potential offered by the data revolution.

A challenging legal landscape

Currently, the most visible piece of data legislation is the GDPR, which sets out how personal data is handled and used. However, other legislative proposals that relate to (personal) data are being developed, and will become increasingly important in the near future. These include the European Data Health Space, the Data Act and the Data Governance Act; these will cover the availability and transferability of scientific and research data between organisations.

PwC Legal will get you ready for the challenges of these Acts; not simply from a compliance point of view; we will also help you spot, at an early stage, any opportunities offered by the framework.





Designing legally-compliant approaches to data-based innovation

In healthcare, being positioned to make the most of the data revolution will be pivotal to your future business success. At PwC Legal, we know the importance of retaining your competitive advantage. We will work with you to make sure you are ready and equipped to benefit from the opportunities that data offers in a way that will not compromise you legally, now or in the future.

In such a rapidly changing landscape, it’s important to know and follow best practices; PwC Legal can advise you on how to adapt while maintaining the continuity of business operations. We will also help you put in place the correct data handling system to ensure your compliance.

Managing data breaches

Security of data is vitally important, but accidents can and will happen. In this event, PwC Legal can help you deal with data breaches and ensure the necessary steps are undertaken in due time. In the unfortunate event that there are data breaches – for whatever reason - PwC can supply you with the necessary legal support and make sure any breaches are properly notified.

Partnerships and data ecosystems

Many of the benefits to come from data will stem from working and pooling with partners. However, in the health sector, data can arise from a number of sources, including hospitals and institutions, often with their own compliance requirements and potentially subject to strict constraints on its use. This leads to complex contractual ecosystems, with differentiated rights and obligations for each party. PwC will develop the appropriate answers and assurances to the relevant data holders.

We can also ensure that any acquisition or partnership you make, or ecosystem that you build, is compliant and that the data is appropriately protected and secured. Furthermore, with the help of our other PwC teams, we can conduct the necessary due diligence to ensure that the provenance of any data you acquire is impeccable.





Unleashing the potential of the European Health Data Space

Many actors in the health sectors are already aware of the potential of the European Data Space (EHDS). This initiative is aimed at providing a connected network where patient health data is interoperable and exchangeable across borders for a multitude of players. While the overarching concept underpinning the EHDS is excellent, questions remain around the practical reality of its future implementation.

PwC Legal can assist those hospitals, universities, institutions and research centres with a smooth transition to the EHDS. We will guide you through the implementation process and advise you on any changes you may need to make while - of course - remaining compliant.

Benefitting from AI 

The use of AI applications will inevitably grow in importance in the healthcare sector, with applications in areas as diverse as accelerating drug research and improving disease screening. Companies will need to embrace this reality in order to survive and evolve for the new markets it will create.

In order to do so, however, companies will need to be compliant with the relevant legislation – such as the AI Act and the AI Liability Directive - from the outset. While the legislation is yet to be finalised, any AI-related plans or projects must recognise its direction of travel in order to be prepared.

PwC Legal and PwC’s connected approach

Thanks to PwC Legal’s strong ties with PwC experts, we can provide a perspective spanning disciplines, specialities and sectors. The benefit of this – particularly given the raft of new data legislation on the horizon – is that PwC Legal is equipped to take a holistic view of the likely impacts, beyond the likely legal ramifications. This perspective means that PwC Legal can not only advise you on any likely risks, we can also easily access in-house expertise to mitigate their impact. 

For example, PwC Legal can tell you what your legal requirements are, and provide you with the cybersecurity expertise to put in place measures to meet them. The PwC forensic experts can then help you investigate a data breach while PwC Legal assists you in drafting, filing and following up the data breach notification with the competent authorities.

Elsewhere, PwC’s AI experts can show you how your patient data - processed using powerful AI techniques - will help revolutionise your research. Meanwhile PwC Legal will protect your interests by ensuring - in advance - that the data in question can be used lawfully and that you acquire full ownership of the potential outcomes of your research.

Thought Leadership

If you want to know more about our insights into the health data environment, read our thought leadership pieces.


Contact us

Karin Winters

Lawyer - Partner, PwC Legal BV/SRL

+32 476 60 26 94


Loïc Delanghe

Lawyer - Senior Managing Associate, PwC Legal BV/SRL

+32 493 53 96 13


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