New patient safety and health information legislation would create an "insurmountable conflict" for the Data Protection Commissioner if it imposes the role envisaged for her office, she has told an Oireachtas committee.
Helen Dixon addressed the Joint Oireachtas Committee on Health last month on the Health Information and Safety Bill, which has been in preparation for many years.
The general scheme of the legislation currently before the Oireachtas envisages that the commissioner would have a role in determining whether health researchers were permitted an exemption from the requirement that individuals give explicit consent for the processing of their health information.
The health committee sought submissions on aspects of the Bill by last Friday.
Officials from the Department of Health told the committee the Bill contained important safety measures to protect patients and that it was also intended to underpin disease registers and to encourage health research in Ireland.
Muiris O’Connor, assistant secretary in charge of research and development at the health analytics section of the Department of Health, addressed the committee on December 14th.
“This Bill aims to facilitate efficient and effective health information systems in the interests of enhancing our capacity to utilise data and information to plan and deliver safe, quality health services,” Mr O’Connor said.
Ms Dixon said her office recognised the intended benefits of the Bill, but it considered the role envisaged for it “would not be appropriate” and may legally conflict with the independent role given to the commissioner under EU law.
Synopsis
While the commissioner gave only a synopsis of her statement orally, the full submission was circulated and published on the Oireachtas website.
Ms Dixon also noted the Bill made a provision for her office to be compensated in monetary terms for arriving at its determination.
“We are concerned that the commissioner may also as a result be perceived as being tainted by financial interests in reaching her decision,” she said in her submission.
Mr O’Connor told the committee health research was extremely important for innovations in health care that could “directly benefit the patient and the health system and there are also benefits for the economy in terms of jobs”.
EU law already governs research ethics approval for clinical trials of medicinal products for human use and medical devices and the Bill will not apply to that research, he added.
The Bill would provide for a new “voluntary research ethics structure” for other health research.
Mr O’Connor said the department would commit to “a series of intensive engagements with the Data Protection Commissioner to work through the issues, which we do not believe are insurmountable”.
“We respect the views of the commission in respect of the role it should appropriately play in the schemes.”
