Health Canada demonstrates that personal information it collects relates directly to the administration of its Non-Insured Health Benefits Program

Complaint under the Privacy Act

March 12, 2018

Summary

1. The complainant alleged that Health Canada required First Nations and Inuit people to provide more personal information than necessary for the adjudication of claims for medical benefits under its Non-Insured Health Benefits (NIHB) Program. According to the complainant, Health Canada’s collection of personal information was beyond that required for the purposes of administering the NIHB Program.
2. The complaint was filed on behalf of more than twenty physicians (the physicians). Their concerns centered around two specific practices:
   1. An alleged requirement for physicians to provide detailed patient information for the approval of drug benefits; and
   2. An alleged requirement for physicians to provide diagnostic information about patients seeking medical transportation and specialist services.
3. The allegation concerning medical transportation and specialist services has been addressed in a separate report.^{Footnote 1}
4. Concerning the issue of the collection of patient information for the approval of prescription drugs, Health Canada submitted that it only collects information that is required for the purpose of providing drug benefits through the NIHB.
5. After reviewing submissions from both parties as well as consulting with the physicians, we determined that the aspect of the complaint that concerns drug benefits is not well-founded. The reasons for this finding are outlined below.

Scope and Methodology

6. The complainant also raised concerns about the adequacy of the Privacy Act (the Act) to protect the personal health information of First Nations and Inuit people, as compared to provincial health privacy legislation. Those concerns were considered outside the scope of our investigation.
7. In conducting our investigation, we reviewed:
   • the mandate of Health Canada and the NIHB Program;
   • the personal information elements Health Canada collects in the administration of the NIHB Program;
   • a sample of drug benefit forms provided by the physicians; and
   • representations submitted by both parties.
8. In the course of our investigation, we consulted with the practicing physicians. Although formal representations in support of the complaint were provided by the complainant’s Office, we also considered physician concerns over patient privacy and the privacy impacts of those concerns on First Nations and Inuit communities.

Relevant Facts and Issues

The NIHB Program

9. Health Canada's NIHB Program is a national program that provides registered First Nations and recognized Inuit residents in Canada with coverage for medically necessary health services not otherwise available through private plans or provincial/territorial health and social programs. NIHB benefits include limited prescription drugs and over-the-counter medications, dental and vision care, medical supplies and equipment, mental health counselling, and transportation to health services not available on reserve or in an individual’s community of residence.
10. In order to support the adjudication of claims under the NIHB Program and to coordinate the processing of those claims with provincial, territorial and private health programs, Health Canada collects personal information about individuals applying for NIHB benefits.
11. Personal information collected by Health Canada under the NIHB Program is collected primarily from health service providers on behalf of individual patients. Health service providers include physicians, nurses, pharmacists, optometrists, dentists, psychologists, social workers, and medical transporters.

Limited Use Benefits

12. The drugs available through the NIHB program are listed on the Drug Benefit List. This list is compiled by Health Canada with the advice of the Canadian Drug Expert Committee, through the Canadian Agency for Drugs and Technology in Heath Common Drug Review, the pan-Canadian Oncology Drug Review, and the NIHB Drugs and Therapeutics Advisory Committee.
13. Three categories of drugs are available through the NIHB Program: Open Benefits^{Footnote 2}, Limited Use Benefits^{Footnote 3}, and Exceptions^{Footnote 4}. At issue in this complaint are the forms used for applying for Limited Use Benefits. Health Canada collects information through Limited Use forms to determine if established criteria to be eligible for a benefit are met. According to Health Canada, the NIHB has over 250 Limited Use forms – each Limited Use drug has its own form.

The Complainant's Position

14. According to the complainant, some of the Limited Use forms request personal information that is unnecessary for the adjudication of a request for prescription drug coverage under the NIHB.
15. We consulted with physicians (the physicians) who provided representations on behalf of the complainant. They argued that, in many cases, Health Canada requests exact diagnostic information on the Limited Use Forms when, in their view, a general range would be sufficient to demonstrate that eligibility criteria have been met. The physicians provided several sample forms where exact information is requested. For example, one form requests “the number of swollen joints” for a medication used to treat arthritis. The physicians argued that Health Canada did not require the exact number of swollen joints to determine if an individual is eligible for the medication. Rather, clinical criteria for the medication states that it is for the treatment of “severe active [Rheumatoid arthritis] with greater than or equal to 5 swollen joints” (emphasis added). According to the physicians, it should be sufficient to indicate that the patient is within the required range – greater than or equal to five swollen joints – as opposed to stating the exact number of swollen joints. The physicians provided several examples of forms that requested exact information rather than ranges set out in clinical criteria.

Health Canada's Position

16. We provided the forms identified by the physicians to Health Canada and asked that it explain the collection of the information for each required data field. Health Canada submitted that the data fields are based on clinical criteria and conditions defined by expert drug-review committees^{Footnote 5} comprised of pharmacists and physicians. Health Canada submitted that the drug-review committees follow an evidence-based approach and consider current medical and scientific knowledge, current clinical practice, health care delivery, and specific client-population health needs.
17. In its response, Health Canada provided an explanation for why it collects the information requested by each data field on each form identified. For example, with respect to the above-mentioned form for arthritis medication, Health Canada provided the following explanation for why it requests the number of swollen joints.

    The exact number of swollen joints is required to determine whether a calculated >20% improvement has occurred between start of therapy and renewal (a range cannot be used to calculate this: the specific number of joints (and other specific parameters) is necessary to evaluate). Information is requested both at baseline (when the client begins the treatment) and when the therapy is renewed, usually after one year of therapy... Biologic therapies such as [this] should only be continued in patients who are responding to the treatment based on objective parameters. If patients are not responding, another therapy should be chosen based on safety for the client and cost-effectiveness for the overall health care system including public drug plan payers. The Canadian Rheumatology Association has reviewed these forms and agrees that the information requested is both reasonable and necessary to ensure patient follow-up and best use of resources.

Applicable Sections of the Act

18. In making our determination, we considered sections 3 and 4 of the Act. We also considered relevant policies, directives and guidelines issued by the Government of Canada in relation to the handling of personal information. This included the Treasury Board of Canada Secretariat’s (TBS) Directive on Privacy Practices. Although the Directive is not legally binding, as a mandatory policy instrument, it can be helpful in identifying and assessing federal obligations with respect to the handling of personal information.
19. Section 3 of the Act defines personal information as information about an identifiable individual that is recorded in any form.
20. Section 4 of the Act provides that personal information collected by a government institution must relate directly to an operating program or activity of the institution.

Analysis and Findings

Is the personal information of individuals at issue?

21. The information at issue includes the name and medical information of individuals. This constitutes personal information as defined by the Act.

Did Health Canada contravene the collection provisions of the Act by collecting information requested on the Limited Use Forms?

22. Our investigation did not examine every Limited Use Form. Rather, we considered those forms identified by the physicians as a representative sample.
23. Section 4 of the Act requires that information collected by a government institution relates directly to an operating program or activity. Health Canada is responsible for administering the NIHB Program. The provision of drugs on the Limited Use Benefits list falls within the scope of the NIHB Program.
24. The information at issue is collected for the purpose of adjudicating requests for drug benefits that fall within the scope of the Limited Use Benefits. In our analysis, we considered whether Health Canada had demonstrated that there was a direct connection between the information collected and the purpose for collection. For each data field we identified, Health Canada provided the purpose for collecting the information at issue as it relates to the adjudication of the respective benefit request.
25. We also asked Health Canada to demonstrate that the information it is collecting is necessary for administering the NIHB Program. For each data field we identified, Health Canada provided an evidence-based explanation for why the personal information at issue is necessary.
26. Therefore, in our view, Health Canada demonstrated that the collection of the personal information at issue is consistent with the provisions of the Act.

Finding

27. In light of the above, this aspect of the complaint is not well-founded.

Other

28. During the course of our investigation, the physicians raised a number of issues related to the provision of health care to First Nations and Inuit people. One specific concern was the length of time taken for the approval of benefits. The physicians argued that the collection of unnecessary information led to situations where patients were not given timely access to treatment. Although such issues were beyond the scope of our investigation, we nevertheless passed on this concern to Health Canada officials working in the NIHB Program.
29. In response to these issues, Health Canada submitted that it has implemented an expedited review process for some drugs. Health Canada committed to continue working with its claim processor in order to expand the number of medications that can be approved using the streamlined process. We encourage Health Canada to continue engaging with its claim processor as well as stakeholders in First Nations and Inuit communities with the aim of providing timely responses to benefit claims.
30. The physicians also raised concerns that some patients have expressed regarding how Health Canada stores, uses, and discloses medical information. For example, some patients who require drug benefits related to mental health have expressed concerns about the Federal government collecting, retaining and using mental health information. These concerns were beyond the scope of our investigation; however, they demonstrate the importance that individuals place on maintaining control over their personal information. Although the principle of individual control over personal information is not unique to the NIHB Program, it is particularly pertinent given the sensitivity of the personal information at issue.
31. To address these concerns, we encourage Health Canada to engage with beneficiaries of the NIHB Program to explain its information-handling practices. In our view, by being more transparent about how it collects, retains, uses and discloses personal information, Health Canada can empower beneficiaries of the NIHB Program to exercise control over their personal information.