The NHS European office and the Royal College of Physicians have warned a new Europe-wide law on data protection could have a negative impact on healthcare provision and erode the quality and effectiveness of health research in the U.K.

The warning comes as the European Parliament (EP) has agreed at committee stage on new legislation that aims to harmonize data protection regulations across the E.U.

The report, by the European Parliament’s Committee for Civil Liberties, Justice and Home Affairs, comes at a time when information governance is high on the agenda of the NHS, following the U.K. government’s broad acceptance in September of the 26 recommendations of Dame Fiona Caldicott's review into information governance. This highlighted the importance of getting right how the NHS manages and uses information and data, which is critical to its ability to work system-wide and deliver care that is truly patient-focused.

The vote marks a key step in the process, which could result in changes to data protection laws at an E.U. level that would involve direct application into U.K. law.

The NHS Confederation's European office has raised concerns that the EP vote creates uncertainty and confusion around the need for consent in processing personal data in a health context. This could create a barrier to the sharing of patient data, which is essential for delivering fast, effective healthcare for patients.

Although the EP has attempted to remove any unnecessary administrative burden on organizations responsible for processing personal data, the report includes a number of administrative responsibilities that are prescriptive and which would impose a significant financial and time burden on the health service.

The proposed changes would erode support for legitimate scientific health research, which could have a direct impact on U.K. citizens' access to life-saving drugs and treatments.

Pamela Forde, data protection officer for the Royal College of Physicians, said, “Patient data is an invaluable resource for health research, forming the basis of studies into the causes and risk factors of disease, and helping researchers identify suitable participants for studies and clinical trials. It is important that this legislation recognizes the crucial role such research plays in maintaining and improving public health—and restores the support for scientific health studies.”

Elisabetta Zanon, director of the NHS European office, said, “Members of the European Parliament have failed to understand the consequences this complex legislation will have on health. They have underestimated the negative impact on patients' access to fast and effective healthcare. We will continue to concentrate all our efforts on ensuring that EU decision makers are made aware of our concerns and that the final legislation does not have a negative impact on patients."