Health regulations will allow use of personal data without consent

New regulations signed into law by Minister for Health Simon Harris will allow health research to be carried out using people's personal data without their explicit consent in certain circumstances.

The Health Research Regulations 2018 provide for the appointment by the minister of a committee that will be able to decide whether the normal legal standard that a person must give such consent for the use of their health data may be overridden.

The regulations, signed earlier this month, are made under the provisions of new data protection legislation.

Mr Harris's department and the Health Research Board (HRB) are currently in the process of establishing the new Health Research Consent Declaration Committee and its secretariat.

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That secretariat will be responsible for putting in place an application process to enable researchers seek a so-called consent declaration from the committee where they are seeking to use personal data without the consent of the individuals – the “data subjects”– involved.

A declaration, if granted, will state that explicit consent is not required by the controller.

Mr Harris will appoint between 15 and 21 members to the committee, including a chair and two deputy chairs. The membership will have to include people with knowledge of data protection law, research ethics, statistics, “or other relevant knowledge”.

It may make a declaration only where it is satisfied that the public interest in carrying out the research “significantly outweighs” the public interest in requiring the explicit consent of data subjects.

Researchers will have to provide the committee with written information demonstrating that the personal data will not be processed in such a way that damage or distress “is, or is likely to be, caused to the data subject”.

The HRB said the application process for researchers would be announced as soon as possible and by no later than November 1st.

“In the meantime, the HRB strongly recommends that researchers evaluate carefully (in consultation with their host organisation’s data protection officer) whether or not any processing of personal data that they have undertaken or which they are planning to undertake for the purposes of health research complies with all of the mandatory suitable and specific measures outlined in the Health Research Regulations 2018,” the board said.