Case Number: 160423

Whether the HSE was justified in its decision to refuse access to records relating to a specified medical procedure used in the treatment of clots at Cork University Hospital (the Hospital) under section 15(1)(a) of the FOI Act on the ground that no such records exist or can be found

Conducted in accordance with section 22(2) of the FOI Act by Stephen Rafferty, Senior Investigator, who is authorised by the Information Commissioner to conduct this review

Background

This review has its background in a previous review carried out by this Office in Case 150306. In that case, the applicant submitted a detailed request to the HSE for both information and records relating to what she described as an "experimental procedure" for the treatment of ischemic stroke carried out at the Hospital from 1 December 2009 to 31 October 2014. At parts one and two of that request, she sought details of the number of patients who underwent a medical procedure she identified as having a variety of descriptions. The remaining parts of her request were for records and/or information relating to the procedure in question. Given the issues that have arisen concerning the precise records sought in this case, it is useful, for ease of reference, to set out in full the wording of the original request:

1. The number of patients who underwent the experimental procedure known inter alia as :

Mechanical clot thrombectomy;
Mechanical embolectomy;
Intra-arterial thrombectomy;
Intra-arterial embolectomy;
Endovascular thrombectomy;
Endovascular mechanical thrombectomy,

for ischemic stroke at Cork University Hospital between 1st December 2009 to 31st December 2013.

2. The number of patients who underwent the experimental procedure known inter alia as:

Mechanical clot thrombectomy;
Mechanical embolectomy;
Intra-arterial thrombectomy;
Intra-arterial embolectomy;
Endovascular thrombectomy;
Endovascular mechanical thrombectomy,

at Cork University Hospital between 1st January 2014 to 31st October 2014.

3. Copies of all internal pathways to be followed by staff at Cork University Hospital in which a reference to such experimental procedure is included;

4. Copies of all internal clinical governance protocols at Cork University Hospital to be adhered to prior to the carrying out of such experimental procedure;

5. Copies of all standard written information sheets given to patients and/or next-of-kin in relation to such experimental procedure at Cork University Hospital.

6. Blank copies of standard consent forms given to patients and/or next of kin in respect of such experimental procedure at Cork University Hospital;

7. Copies of all emails, reports and other correspondences in relation to the experimental mechanical thrombectomy for acute stroke between 1st January 2013 and 19th February 2015 between [a named doctor in Sweden] and [a named doctor at Cork University Hospital];

8. A copy of the current Data File for patients who have undergone the experimental procedure as described above at Cork University Hospital;

9. The number of occasions in which a Stryker/Concentric Medical clot retrieval device was selected and deployed as primary instrument in the experimental procedure, between the following dates:

- 1st December 2009 to 31st December 2013
- 1st January 2014 to 31st October 2014

10. The number of occasions in which a Covidien/Medtronic clot retrieval device was selected and deployed as primary instrument in the experimental procedure, between the following dates:

- 1st December 2009 to 31st December 2013
- 1st January 2014 to 31st October 2014

11. Copies of all study protocols for trials investigating the experimental procedure as described above, and the disclosure of the study sponsor and lead investigators of such trials.

The HSE refused the request both at original and internal review decision stage on the ground that no such experimental procedures or trials were undertaken at the Hospital and that it held no relevant records. It did, however, acknowledge that the Hospital performed a procedure known as thrombectomy over the past number of years.

During the course of the review in Case 150306, the HSE provided the applicant with a certain amount of information relating to her request. However the applicant was not satisfied with the level of information provided. In my decision, I acknowledged that some issues had arisen as a result of the applicant's description of the procedures as experimental. However, I found that the HSE had failed to clarify the matter with the applicant and that it had not taken all reasonable steps to locate all relevant records coming within the scope of the request. I annulled the HSE's decision on that basis and directed it to undertake a fresh decision making process on the request. I suggested that the HSE should clarify with the applicant exactly what records and information she was seeking before processing the request afresh.

The HSE subsequently informed this Office that it attempted to clarify the nature and scope of the applicant's request in advance of issuing a new original decision. However, it appears that the parties were unable to agree a mutual understanding of the precise nature of the request. In a letter of 5 May 2016 to the HSE, the applicant stated the following:

"In the context of experimental surgery being carried out on patients at Cork University Hospital - whether as part of a randomised controlled trial or as single arm individual studies - my request dated 27th February 2015 could not be more transparent and clear."

The HSE issued a fresh decision on 19 May 2016, in which it stated that the Hospital "has not partaken in any clinical trials or single arm studies in the area of stroke intervention and no experimental surgery in this area has been carried out". It refused the request under section 15(1)(a) of the Act on the ground that no relevant records exist. The applicant sought an internal review of that decision on 13 June 2016. She argued that the HSE's statement was at odds with a statement she alleged was made by Professor David Williams of the Royal College of Surgeons and published in the media on 12 February 2015 that "[t]he clot retrieval procedure, known as endovascular treatment (ET), has already been given to Irish stroke patients in trials in Beaumont Hospital and Cork University Hospital". The HSE affirmed its decision to refuse the request on 23 June 2016. It stated that the study referred to in the media article did not involve the Hospital.

On 3 October 2016, the applicant sought a review by this Office of the HSE's decision. She included a copy of an online media article that cited Professor Williams as having stated that "The clot retrieval procedure, known as endovascular treatment (EF), has already been given to Irish stroke patients in trials in Beaumont Hospital and Cork University Hospital"

In conducting this review I have had regard to the correspondence between the applicant and the HSE, and to correspondence between this Office and both the applicant and the HSE on the matter.

Scope of Review

Given that much of the difficulty in identifying the precise scope of the applicant's request stemmed from her description of the medical procedures as experimental, I contacted the applicant by email on 20 December 2016 to seek clarification of the matter. I drew the applicant's attention to the fact that the HSE had stated, on a number of occasions, that the Hospital had, indeed, carried out certain procedures during the period concerned, which it described, inter alia, as "intra-arterial procedures for stroke". I asked the applicant to state whether she was seeking records relating to the procedures the Hospital confirmed it had undertaken, regardless of whether or not it deemed those procedures to be experimental or part of a trial or whether she was seeking records relating to other experimental procedures that were carried out excluding the procedures that the HSE has already confirmed were undertaken.

In her response of 5 January 2017, the applicant confirmed that she was seeking access to records relating to the procedures the Hospital confirmed it had undertaken. This Office subsequently informed the HSE of the clarification provided by the applicant. Accordingly, this review is concerned solely with the question of whether the HSE was justified in refusing access to records sought by the applicant relating to procedures carried out at the Hospital on the ground that no such records exist or can be found.

Preliminary Matters
As both parties to the review are aware, while the FOI Act provides for a right of access to records held by FOI bodies, requests for information, as opposed to requests for records, are not valid requests under the Act. The Act does not require FOI bodies to create records if none exist, apart from a specific requirement to extract records or existing information held on electronic devices. Furthermore, the Act does not generally provide a mechanism for answering questions, except to the extent that a question can reasonably be inferred to be a request for a record containing the answer to the question asked or the information sought.

Secondly, it is important to note that this review is not concerned with the question of what records should exist. If a record does not exist, that is the end of the matter, regardless of the applicant's views as to the appropriateness or otherwise of the absence of certain records. However, it is incumbent on the HSE to explain to this Office why it considers that the records do not exist.

Analysis and Findings

Section 15(1)(a) - Adequacy of Search
Section 15(1)(a) of the Act provides for the refusal of a request where the records sought do not exist or cannot be found after all reasonable steps to ascertain their whereabouts have been taken. The Commissioner's role in a case such as this is to review the decision of the FOI body and to decide whether that decision was justified. This means that I must have regard to the evidence available to the decision maker and the reasoning used by the decision maker in arriving at his/her decision and also must assess the adequacy of the searches conducted by the public body in looking for relevant records.

The HSE made a detailed submission to this Office on 20 February 2017. In an email dated 20 April 2017, Mr O'Gorman of this Office provided the applicant with the details of the searches undertaken by the HSE in an effort to locate relevant records. While I do not propose to repeat those details in full, I will refer to them for the purposes of this decision.

In relation to parts 1 and 2, the HSE stated that HSE hospitals record activity in the Hospital In-Patient Enquiry (HIPE) information system, which is the principal source of national data on activity from acute hospitals. It stated that since March 2014 all stroke cases are recorded on the National Stroke Register, which has formal links to HIPE and that no formal arrangements were in place prior to that date. In summary, the HSE stated that it has provided the number of patients who underwent the procedure of which it has a record for the time frame stipulated.

The HSE further stated that it has no records relating to any other parts of her request apart from the information previously released. It stated that it consulted with relevant individuals on the matter and searched in the locations and databases where it might expect to find relevant records. No relevant information or records were identified, save for information relevant to part 2 of the applicant's request, which had been previously provided to her, and related records relevant to part 8 of her request, which are dealt with below. I find no basis for disputing the HSE's statements in this regard.

In response to the search details provided by the HSE, the applicant called into question the adequacy of the steps taken by the HSE, in particular the relative seniority and knowledge of individuals consulted, and the truth of certain statements made by the HSE. The applicant refused to accept that no trials of intra-arterial procedures for stroke were undertaken in the Hospital.

In relation to part 1 of her request, the applicant stated that the HSE had previously set out in an FOI decision of 22 June 2015 that the procedure at issue had been carried out at the Hospital over the past number of years "resulting in an average of 1 patient per month". The applicant suggested that this indicated that the HSE did in fact hold a record containing the number of patients who underwent the procedure at issue.

In response, the HSE stated that the information in question was based on a presentation previously given by a research registrar where it was identified that the Hospital had carried out 20 intra-arterial procedures during the period 1 July 2011 to 31 March 2013 but that no names or medical record numbers were included in the presentation. It stated that the information was provided to the applicant in good faith in order to assist her. It further stated that while the Hospital had no reason to doubt the accuracy of the information, the procedures were not recorded on the HIPE system in the time period specified by the applicant.

The position of the HSE is that the Hospital does not hold records, or in the case of part 2 of her request, further information, relevant to parts one to seven and nine to eleven of the applicant's FOI request. While the applicant may not be satisfied with the responses, I have no reason to doubt the HSE's submission. Having considered the HSE's statements and explanations on the matter, I find that the HSE was justified in refusing the applicant's request at parts one to seven and nine to eleven under section 15(1)(a) of the FOI Act.

Section 37- Personal Information
At part 8 of the applicant's original request, she sought a copy of the current data file for patients who had undergone the procedure at issue at the Hospital. The HSE identified seven instances where patients underwent the procedure. The HSE stated that it was of the view that the medical records of the patients in question are exempt from release under section 37(1) of the FOI Act.

Section 37(1) of the FOI Act provides that a public body shall refuse to grant a request where access to the record sought would involve the disclosure of personal information relating to an individual or individuals other than the requester. For the purposes of the Act, personal information is information about an identifiable individual that (a) would, in the ordinary course of events, be known only to the individual or his/her family or friends, or (b) is held by an FOI body on the understanding that it would be treated by it as confidential. Section 2 of the Act further details fourteen specific categories of information which is personal information without prejudice to the generality of (a) and (b) above, including "... (i) information relating to the educational, medical, psychiatric or psychological history of the individual...".

The files sought are the medical files of the patients in question. It is apparent that the files sought would contain inherently personal information, including personal medical information, of a very sensitive nature relating to persons other than the applicant. The HSE contended that the FOI Act does not expect an FOI body to redact the medical records of third parties to satisfy an FOI request from a third party. It argued, in any event, that because the sample size of seven is small, the disclosure of specific information held on file relating to a patient may result in the disclosure of information relating to an identifiable individual. In the circumstances of this case, I agree. I am satisfied that granting access to the records sought would involve the disclosure of personal information relating to third parties, and I find, therefore, that section 37(1) of the FOI Act applies.

Section 37(2) of the FOI Act also sets out certain circumstances in which 37(1) does not apply. However, I am satisfied that none of those circumstances arise in this case. Furthermore, section 37(5) provides that a request that would fall to be refused under section 37(1) may still be granted where, on balance (a) the public interest that the request should be granted outweighs the right to privacy of the individual to whom the information relates, or (b) the grant of the information would be to the benefit of the person to whom the information relates.

On the facts of this case, I am satisfied that the release of the records at issue would not be of benefit to the seven patients in question, and I therefore find that section 37(5)(b) does not apply. On the matter of whether section 37(5)(a) applies, the question I must consider is whether the public interest in granting the request outweighs, on balance, the public interest in protecting the privacy rights of the persons to whom the information relates.

I am of the view that while there is a public interest in the HSE and the Hospital being open, transparent and accountable in the manner in which they perform their functions, the FOI Act also recognises the public interest in the protection of the right to privacy, both in the language of section 37 and in the Long Title to the Act (which makes clear that the release of records under FOI must be consistent with the right to privacy). It is also worth noting that the right to privacy has a constitutional dimension, as one of the unenumerated personal rights under the Constitution. Privacy rights will therefore be set aside only where the public interest served by granting the request (and breaching those rights) is sufficiently strong to outweigh the public interest in protecting privacy. I am also cognisant of the fact that disclosure of a record under FOI is, in effect, disclosure to the world at large. Accordingly, I find that the public interest in the release of the information at issue does not, on balance, outweigh the public interest in protecting the privacy rights of the individuals to whom the information relates. I find, therefore, that section 37(5)(a) does not apply.

In conclusion, therefore, I find that the HSE was justified in refusing access to the records it identified as relevant to part 8 of the applicant's request under section 37(1) of the Act.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby vary the decision of the HSE. I find that the HSE was justified in its decision to refuse the majority of the request under section 15(1)(a) of the Act, on the basis that the records sought do not exist. I vary the HSE's decision in so far as it applies to part 8 of the applicant's request. I find the records coming within the scope of that part of the request are exempt from release under section 37 of the Act.

Right of Appeal

Section 24 of the FOI Act sets out detailed provisions for an appeal to the High Court by a party to a review, or any other person affected by the decision. In summary, such an appeal, normally on a point of law, must be initiated not later than four weeks after notice of the decision was given to the person bringing the appeal.

Stephen Rafferty
Senior Investigator