May 4, 2011
In-person and phone Attendees:
- Rob Connor, Department of Human Services (DHS)
- Mary Lucie, Northwestern Memorial HealthCare
- Maria Pekar, Loyola University Health System
- Tiefu Shen, Department of Public Health (DPH)
Office of Health Information Technology (OHIT)
- Mark Chudzinski
- Naomi Chung
- Vaughn Ganiyu
- Krysta Heaney
- April Schweitzer
Maria Pekar, as co-chair of the Work Group, welcomed participants to the call at 10:33 a.m., hosted by OHIT at the State of Illinois J.R. Thompson Center in Downtown Chicago, with a telephone conference call-in number. It was confirmed that notice of the meeting and the agenda were posted on the OHIT Web site and at the Chicago meeting location no later than 48 hours prior to the meeting. Roll was taken, and the ability of those attending by telephone to hear and participate was confirmed. Minutes from the April 6, 2011, Work Group meeting were distributed prior to the meeting and were subsequently approved without objection.
The Work Group was asked to consider several questions posed by the Genetic Testing/Information Work Group.
Participants, initially discussing the Genetic Privacy Information Act, noted that the Act does not define "de-identification," and does not specifically address whether a disclosing entity can de-identify data. The group discussed several practical methods hospitals are currently using to identify what constitutes genetic information, and what processes are in place to obtain further consent with regards to such information.
Participants then discussed the Genetic Counselor Licensing Act, which requires particular consent, but mainly focuses on the definition of genetic counseling, and does not specifically discuss research.
The following is a summary of the questions posed by the Genetic Testing/Information Work Group, and the discussion that followed:
- What limits, if any, should there be on the HIE for purposes of disclosing information for research use?
- This Work Group may recommend that the federal framework be adopted in Illinois
- Will the HIE become a repository for research purposes?
- It is unclear. One of the benefits of an HIE is that it may become a vast repository of data, which could be used for research purposes; however, there would undoubtedly need to be restrictions placed on the release of data.
- Are there any bio-bank connection(s) planned? If so, how will data be stored? Can information be de-identified?
- To date, the Work Group has not discussed bio-banking. However, bio-banks could be part of research and, if the framework dictates, would fall under the Institutional Review Board (IRB). The IRB could also serve as a privacy board, and would be bound by HIPAA regulations.
- The HIE may become a repository in the future. Thus, we may need one definition for raw data, and one definition for manipulated data.
- IDPH already has general guidelines regarding data usage for research, and has developed an algorithm for de-identification, using the statistician's approach allowed under HIPAA.
- What limits, if any, should be placed on who can access the HIE for research (e.g., insurers, pharma, etc.) How will this be monitored (generally and specifically with respect to research)?
- It may be worthwhile to find out what the Center for Disease Control's (CDC) policies are on releasing data.
- What information needs to be shared with the public, as to the potential use of the HIE for research?
- If we follow the IRB model, there would be community representatives, and appropriately disclosing risks would be required.
- Does the HIE need a Privacy Board/IRB? Should the HIE rely upon providers to obtain IRB approval?
- Yes, there needs to be an IRB, however the HIE could designate another IRB to serve as the HIE IRB.
- Should there be an Advisory Committee, with representatives from the public, to provide oversight for any research use of the HIE?
- Yes, existing IRB guidelines following the common rule should be employed.
- What is the role of public health agencies/authorities in genetics research that could involve the HIE?
- The HIE could gather data from state agencies, if it was a repository.
- What is the potential impact of de-identifying data on population-based studies (e.g., environmental issues that are focused on specific geographic areas/communities)?
- There are always risks and benefits. An IRB would provide for accountability, and risks can be mitigated if proper controls are put in place.
The initial meeting of the HIE Authority was held last week.
SB1234, was assigned to the judiciary committee and SB1338, was assigned to the public health committee.
April and Naomi have each agreed to review about 30 statutes in an effort to complete the statutory grid. Please work to complete all statutory review in the next month. If you cannot complete the review you volunteered for, please let April know as soon as possible so your statutes can be re-assigned.
The statutory grid may serve as a supplement to our white paper. Mark will check with the executive committee about whether the grid will need to be put into a different format.
There were no comments offered in response to Maria's invitation for public comment.
The meeting adjourned at 11:29 a.m.