British Columbia's Office of the Information and Privacy Commissioner (OIPC) recently released a report that will be of interest not just to the BC healthcare system and BC public bodies subject to BC's Freedom of Information and Protection Act (FOIPPA), but also to suppliers and advisors working in the healthIT sector. The report identifies numerous deficiencies in the implementation of an electronic health information system, including unauthorized data flows, inadequate security protection, and non-compliant records storage practices. It also provides detailed recommendations on operationalizing healthIT software and systems to meet BC public sector privacy law requirements.
OIPC Investigation Report F10-02 examines the electronic health record system known as the Primary Access Regional Information System (PARIS) used by the Vancouver Coastal Health Authority (VCH). VCH is one of five regional health authorities in BC, and delivers health services to Vancouver, Richmond, North and West Vancouver, along the Sea-to-Sky Highway, the Sunshine Coast, and the Central Coast. VCH introduced PARIS in 2001 for use by its personnel (doctors, nurses, counsellors, administrative staff, etc.) and contractors in its community-based programs delivered outside of acute care hospitals. There are about 400 of these users of PARIS, which houses sensitive personal health information such as records of health services deliveries, diagnoses, and case notes.
The report identifies various deficiencies in how VCH implemented the PARIS software. At the outset of the report, the OIPC noted that these deficiencies were not the result of VCH's software product used for PARIS, but rather due to the "lack of a proper privacy lens" being applied to operationalizing the software. This observation is illustrative of the fact that Canadian privacy laws, such as FOIPPA, do not typically contain prescriptive requirements for types of products (such as software products) but rather impose obligations on organizations for their privacy practices. In other words, a product per se usually cannot be said to meet or not meet Canadian privacy law requirements, since the question is whether the organization has operationalized the product as part of its practices in a way that allows the organization to meet the requirements of privacy laws.
Access to Information was "Team-Based" not "Role-Based"
The OIPC criticized the access model for users of PARIS as being "team-based" rather than "role-based." Access to personal health information in PARIS was implemented on the basis of membership in multi-disciplinary teams comprising doctors, nurses, therapists, counsellors, administrative staff, etc. This "team-based" access, the OIPC determined, permitted too many users to have access to too much information they didn't need to see in order to do their jobs.
By contrast, "role-based" access uses professional credentials and job titles of users to restrict access to information on the basis of well-defined roles within the organization. The role assigned to the user is based on the tasks and services the user provides. "Role-based" access was considered to be more aligned with the principle of "need-to-know" access to personal information. The OIPC described "role-based" access as being the national and international standard for access control for electronic health records. The roles should be centrally assigned to ensure that privacy principles are reflected when assigning roles. The OIPC opined that "role-based" access should be coupled with the requirement of there being a clinical relationship (i.e., access should be limited to only those users who are providing clinical care to a particular patient).
Unauthorized Data Flows
The OIPC identified various information flows between VCH and the BC Ministry of Health (MoH) as not authorized under FOIPPA. This might seem surprising, given that the MoH and the health authorities are all part of the same public health care system. The basis for these findings, however, was that the MoH and the health authorities are separate "public bodies" under FOIPPA, such that the information flows between them require separate legislative authorization. For example, the OIPC found that VCH's collection from the MoH of demographic and personal health number information on patients was unauthorized under FOIPPA because it was unnecessary for operating VCH's health care programs — VCH had alternative means to collect and verify the information (namely, directly from the patients).
The OIPC also found that VCH had provided inadequate notice to patients of the purposes and authority for the collection, use, and disclosure of information in PARIS. The OIPC recommended that VCH develop more comprehensive Web pages and notices for these matters.
The OIPC opined that most of the deficiencies identified by the report in terms of authority, consent and disclosure to the sharing of information could be addressed by designating PARIS a "health information bank" under BC's E-Health (Personal Health Information Access and Protection of Privacy) Act. This Act allows for designation by the Minister of Health Services of electronic databases, with designation serving the dual function of providing (i) the legislative authority for various stipulated information flows between the MoH and health authorities as part of the healthcare system, and (ii) notice to the public of those information flows.
The OIPC did uphold a "secondary use" of PARIS data for health program evaluation as valid and reasonable. Likewise, it accepted secondary uses of de-identified data for research and planning purposes on the basis that the information had been de-identified.
Relevant to the permissible contracting practices for health information disclosures between entities was the OIPC's discussion of information-sharing agreements. Given the sensitivity of personal health information, the OIPC stated that information-sharing agreements should not simply contain broad covenants to comply with privacy laws, but rather must state the specific obligations of data recipients, including matters such as encryption, secure storage, retention schedules and requirements for secure disposal.
The OIPC found that patients were not routinely informed of their option to "mask" their personal health information in PARIS. "Masking" is the ability to mark information so that access to it is restricted within the electronic system by users of the system. PARIS had masking functionality and VCH-permitted masking. The OIPC indicated that patients should be advised of their option to "mask" information without having to justify their choice, and should receive clinical advice as to the implications of masking.
Inadequate Security Protection
The OIPC found that the security arrangements for PARIS did not meet FOIPPA's reasonableness standard for security arrangements against risks such as unauthorized access, collection, use, disclosure or disposal. Given what was described in the report as the large number of serious security deficiencies, the OIPC opted not to detail them but instead highlighted what it described as the following "core security standards" for major electronic health information systems:
- Written procedures and controls must be in place to protect the security of the system and to permit an assessment as to whether they are being followed.
- Controls to detect, prevent and log unauthorized data exchanges must be in place.
- Production or "live" data containing personal health information must not be used for development or testing of systems (fictitious or anonymized data should be used instead).
- Users of the electronic system must be assigned access on a role-based, need-to-know basis (discussed above), and access disabled when the user leaves their position with the VCH.
- Firewalls should exist along the perimeter and also internally, and inappropriate access detected and monitored.
- Personal health information should always be encrypted during transmission and storage.
- All network services must be approved by management, and systems upgraded or patched to the latest version so as to be more secure against hacking.
Non-Compliant Records-Storage Practices
The OIPC found that all records were retained in PARIS indefinitely. It said that users should not have access to personal information that is not required for the current delivery of health services. Accordingly, the OIPC recommended that records should be retained in PARIS no longer than is required for the delivery of health services, and after that should be archived and access strictly limited.
The OIPC found that inadequate information was provided to patients about their rights under FOIPPA to access records containing their personal information that are in the control of the public body.
Privacy Impact Assessments
The OIPC held that public bodies under FOIPPA must perform comprehensive privacy impact assessments (PIAs) that will enable an assessment of whether a proposed system, program, policy, or legislation complies with FOIPPA and has any privacy impacts. PIAs should be done at the conceptual, design, and implementation stage of an electronic system. After the system has been operationalized, the PIAs should be reviewed and updated on a regular basis (at a minimum, whenever there is a material change to the system).
Resource Allocation and Training
In the OIPC's opinion, it is essential that public bodies assign resources to ensure compliance with FOIPPA. In addition, ongoing training is required for all employees who have access to personal information, and employees should sign confidentiality undertakings on an annual basis.
The BC OIPC's report on VCH's PARIS electronic records system provides many useful guideposts and observations. With the scale of current and planned investments in healthIT projects, those involved in health privacy, healthIT, or BC public sector privacy law will find the report well worth reading.
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