Sunday, April 16, 2017

Subject: RE: Medical information provided to Pure North S'Energy Foundation by the government of Alberta through AHS (AC434857)


I am curious about how Pure North S'Energy Foundation got access to patient information when it was not doing a study and there was no ethical review of the work it was doing. I mean if it was not doing a research project that is governed by established rules for an ethical review and other requirements set out by AHS then why was it given access to data and who approved of this access?
When this information was given to this Foundation what was this information used for? 
Then when data was collected from guinea pig citizens what sorts of rules were followed by the Foundation when it gave the data to university researchers? Since this work was paid for by the public and if it occurred in AHS sites--what were the rules about the storage and release of such data?
And who do we complain to when we find the entire information release and use to be problematic? Do we go to the FOIP person at the GOA or do we go outside the GOA?
From:  <AlbertaConnects@gov.ab.ca> Date: Sun, Apr 16, 2017 at 1:09 AM Subject: RE: Medical information provided to Pure North S'Energy...
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From: <AlbertaConnects@gov.ab.ca>
Date: Sun, Apr 16, 2017 at 1:09 AM
Subject: RE: Medical information provided to Pure North S'Energy Foundation by the government of Alberta through AHS (AC434857)
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Medical information provided to Pure North S'Energy Foundation by the government of Alberta through AHS
I have some questions about the release of patient information to Pure North S'Energy Foundation by the government of Alberta through AHS. From this newspaper article I understand that this foundation was given patient information: http://www.cbc.ca/news/canada/edmonton/pure-north-unproven-benefits-1.4053866 Alberta rushed $10-million grant, eliminated ethical oversight, for unproven health program Review found Pure North program could not prove health or economic benefits By Jennie Russell, Charles Rusnell, CBC News Posted: Apr 04, 2017 5:00 AM MT Last Updated: Apr 04, 2017 5:00 AM M "The Government of Alberta, and Alberta Health in general, isn't interested in funding research projects," Carter said. "They're interested in funding health care for Albertans. So they decided to shift the project and we agreed to shift the project to providing direct health care." Internal documents, however, show that immediately after Pure North received the funding, Markin began seeking access directly through health minister Fred Horne to anonymized patient data from Alberta Health Services. Markin wanted access to the data so university researchers could assess the efficacy of the recently funded seniors program. Pure North collects detailed medical information from its participants, including blood samples, and has built a "mega-database" to which university researchers have been provided access. The foundation, however, insists it is not conducting research but instead gathers data to gauge the efficacy of its program. Its spokesperson, Stephen Carter, told CBC News the information provided to researchers is simply a "secondary" use of that data. I have several questions about this transfer of information first from government to the foundation and from the foundation to the university researchers. 1) It was my understanding that patient information is only released for studies and folks have to go through a particular mandatory review process prior to the provision of patient data. For example to access Netcare data there is this protocol that has to be followed as noted below. http://www.albertahealthservices.ca/research/page8594.aspx As custodians of health information, AHS must evaluate applications for data for studies approved by Research Ethics Boards (REBs) prior to disclosing health information, performing data matching or any other services requested to facilitate the research project. If the custodian decides to support the research as requested, the custodian must impose the conditions suggested by the REB and enter into an HIA Research Agreement in which the researcher agrees to: Comply with HIA regulations; Any conditions imposed by the custodian relating to the use, protection, disclosure, return or disposal of the health information; and Any requirement imposed by the custodian to provide safeguards against the identification, direct or indirect, of an individual who is the subject of the health information. This can even include requiring consent (even if the REB has waived it) if the information is particularly sensitive. The most common forms to access data include: Data Extraction Paper Charts Direct System Access (Including Alberta Netcare Portal) ********************************************** Was there a specific protocol followed prior to the release of the data on patients? 2) Why was the data even provided to Pure North S'Energy Foundation in the first place since it was not doing a research study? There was no ethics board review of the study thanks to the transformation of the study into a health program by government so why was this foundation given access? 3) What are the rules for release of patient information when there is no study and there is only health services apparently being offered to a group of guinea pig citizens? 4) What sort of consent forms were filled in for these guinea pig citizens so that they would take part in a health program of dubious benefit and possible adverse side effects? 5) Were there any problems associated with this health program that was funded by Alberta Health? 6) What sort of liability is present for the public purse when information is released in a manner that seems rather unregulated to a private foundation to use as it sees fit? 7) What sort of liability is present when the foundation then generates information (data) out of this quack science project that we pay for involuntarily and this information is released to universities for further quack science work? 8) Who are the decision makers for the release of information and who can we complain to about this matter of what appears to be unregulated release of patient data? Do we complain to the government FOIP person and if so who is this person? Please provide a contact. Thank you for your help. Sincerely, Julie Ali http://ipo.ualberta.ca/en/Health-Information-Act/Research-and-Netcare.aspx Research and Netcare Expanded Access to Netcare for Research The Alberta Netcare Portal (Netcare) is a viewer of health information provided from many source systems across the province. It is a powerful clinical tool and increasingly investigators are requesting access to this information for research purposes. As a custodian of Netcare, Alberta Health Services (AHS) is bound by the Information Exchange Protocol (IEP) (2007) when providing access for research personnel. Because ANP was developed primarily as a clinical tool, the rules around access for research are currently quite limiting. Revisions to these rules are expected to be tabled in the next session of the Alberta Legislature at which time we will have an opportunity as a collective community of investigators and research administrators to review and comment on how well the changes respond to our evolving research environment. In the meantime, AHS Research Administration has collected specific examples of research activities that are consistent with the intent of the IEP but under the existing interpretation could not acquire data directly from Netcare. The AHS Chief Privacy Officer, Mike Tolfree, has reviewed the AHS obligation under the IEP in light of these examples and has offered an expanded interpretation of the IEP that permits AHS to offer better (albeit not ideal) access for researchers while we await the changes in legislation. Thanks to Drs. Lawrence Richer, Richard Fedorak and Michael Hill who gathered comments from the research communities at the Universities of Alberta and Calgary to inform the drafting of these materials. The new criteria for access and process for obtaining access are available at: http://www.albertahealthservices.ca/8594.asp To see AHS memo on Accessing Information from the Alberta Netcare Portal (ANP) for Research Purposes click here. http://www.albertahealthservices.ca/research/page8594.aspx Data & Health Information Resources When Planning Your Study: Identify Your Data Source(s) Research Facilitation offers consultation to determine data sources most suited to your research questions. To learn more about the availability of AHS data sources for research contactResearch.Facilitation@ahs.ca. For information on criteria and procedures for accessing data for research, contact Research.Administration@ahs.ca. When Conducting Your Study Research Ethics Boards (REBs) and AHS, as data custodians, have different responsibilities under the Health Information Act when health information is requested for use and disclosure for clinical research purposes. As custodians of health information, AHS must evaluate applications for data for studies approved by Research Ethics Boards (REBs) prior to disclosing health information, performing data matching or any other services requested to facilitate the research project. If the custodian decides to support the research as requested, the custodian must impose the conditions suggested by the REB and enter into an HIA Research Agreement in which the researcher agrees to: Comply with HIA regulations; Any conditions imposed by the custodian relating to the use, protection, disclosure, return or disposal of the health information; and Any requirement imposed by the custodian to provide safeguards against the identification, direct or indirect, of an individual who is the subject of the health information. This can even include requiring consent (even if the REB has waived it) if the information is particularly sensitive. The most common forms to access data include: Data Extraction Paper Charts Direct System Access (Including Alberta Netcare Portal) Data Extraction Paper Charts Direct Electronic Medical Records Details Data can often be extracted and linked for research purposes from AHS clinical and corporate systems. If you require assistance in identifying appropriate data source(s) for your research project and for information about AHS Data Reporting Repository (AHSDRR), please contact Research.Facilitation@ahs.ca. Research Facilitation provides data extraction and linkage services from AHS Administrative Data Sources for most Research Ethics Board approved projects free of charge. Charges may apply to highly complex projects and industry-funded research. Services include: Refine research question to make it suitable for analysis using administrative data sources Identify appropriate administrative data sources Identify and operationalize cohorts using administrative data Identify and operationalize outcome measures Identify and operationalize covariates and confounding factors Prepare a data acquisition plan that describes steps to take in acquiring data Share Report a problem Go to top GIVE PAY PATIENT FEEDBACK About this site CONTACT Contact Us Emergency Numbers 811 Health Link Patient Feedback Continuing Care Concerns DATA & REPORTING Emergency Wait Times EMS Response Times Expense Reporting Restaurant Inspections Wait Times Reporting GET INVOLVED Advisory Councils Give: Foundations & Health Trusts Patient & Family Advisors Thank the People Who Care Volunteer at AHS GET MOBILE Download our mobile apps © Alberta Health Services 2017 Terms of UsePrivacy Statement What sort of
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I have some questions  about the release of patient information to Pure North S'Energy Foundation by the government of Alberta through AHS.

From this newspaper article I understand that this foundation was given patient information:


Alberta rushed $10-million grant, eliminated ethical oversight, for unproven health program

Review found Pure North program could not prove health or economic benefits

By Jennie Russell, Charles Rusnell, CBC News Posted: Apr 04, 2017 5:00 AM MT Last Updated: Apr 04, 2017 5:00 AM M


"The Government of Alberta, and Alberta Health in general, isn't interested in funding research projects," Carter said. "They're interested in funding health care for Albertans. So they decided to shift the project and we agreed to shift the project to providing direct health care."
Internal documents, however, show that immediately after Pure North received the funding, Markin began seeking access directly through health minister Fred Horne to anonymized patient data from Alberta Health Services. Markin wanted access to the data so university researchers could assess the efficacy of the recently funded seniors program.

Pure North collects detailed medical information from its participants, including blood samples, and has built a "mega-database" to which university researchers have been provided access.
The foundation, however, insists it is not conducting research but instead gathers data to gauge the efficacy of its program. Its spokesperson, Stephen Carter, told CBC News the information provided to researchers is simply a "secondary" use of that data.


I have several questions about this transfer of information first from government to the foundation and from the foundation to the university researchers.

1) It was my understanding that patient information is only released for studies and folks have to go through a particular mandatory review process prior to the provision of patient data.

For example to access Netcare data there is this protocol that has to be followed as noted below.

http://www.albertahealthservices.ca/research/page8594.aspx

As custodians of health information, AHS must evaluate applications for data for studies approved by Research Ethics Boards (REBs) prior to disclosing health information, performing data matching or any other services requested to facilitate the research project.
If the custodian decides to support the research as requested, the custodian must impose the conditions suggested by the REB and enter into an HIA Research Agreement in which the researcher agrees to:
  1. Comply with HIA regulations;
  2. Any conditions imposed by the custodian relating to the use, protection, disclosure, return or disposal of the health information; and
  3. Any requirement imposed by the custodian to provide safeguards against the identification, direct or indirect, of an individual who is the subject of the health information. This can even include requiring consent (even if the REB has waived it) if the information is particularly sensitive.
The most common forms to access data include:
  • Data Extraction
  • Paper Charts
  • Direct System Access (Including Alberta Netcare Portal)
**********************************************
Was there a specific protocol followed prior to the release of the data on patients?


2) Why was the data even provided to Pure North S'Energy Foundation in the first place since it was not doing a research study? There was no ethics board review of the study thanks to the transformation of the study into a health program by government so why was this foundation given access?

3) What are the rules for release of patient information when there is no study and there is only health services apparently being offered to a group of guinea pig citizens?

4) What sort of consent forms were filled in for these guinea pig citizens so that they would take part in a health program of dubious benefit and possible adverse side effects?

5) Were there any problems associated with this health program that was funded by Alberta Health?

6) What sort of liability is present for the public purse when information is released in a manner that seems rather unregulated to a private foundation to use as it sees fit?

7) What sort of liability is present when the foundation then generates information (data) out of this quack science project that we pay for involuntarily and this information is released to universities for further quack science work?

8) Who are the decision makers for the release of information and who can we complain to about this matter of what appears to be unregulated release of patient data? Do we complain to the government FOIP person and if so who is this person? Please provide a contact.


Thank you for your help.
Sincerely,

Julie Ali 


http://ipo.ualberta.ca/en/Health-Information-Act/Research-and-Netcare.aspx

Research and Netcare

Expanded Access to Netcare for Research

The Alberta Netcare Portal (Netcare) is a viewer of health information provided from many source systems across the province. It is a powerful clinical tool and increasingly investigators are requesting access to this information for research purposes.

As a custodian of Netcare, Alberta Health Services (AHS) is bound by the Information Exchange Protocol (IEP) (2007) when providing access for research personnel. Because ANP was developed primarily as a clinical tool, the rules around access for research are currently quite limiting.

Revisions to these rules are expected to be tabled in the next session of the Alberta Legislature at which time we will have an opportunity as a collective community of investigators and research administrators to review and comment on how well the changes respond to our evolving research environment.

In the meantime, AHS Research Administration has collected specific examples of research activities that are consistent with the intent of the IEP but under the existing interpretation could not acquire data directly from Netcare.

The AHS Chief Privacy Officer, Mike Tolfree, has reviewed the AHS obligation under the IEP in light of these examples and has offered an expanded interpretation of the IEP that permits AHS to offer better (albeit not ideal) access for researchers while we await the changes in legislation.

Thanks to Drs. Lawrence Richer, Richard Fedorak and Michael Hill who gathered comments from the research communities at the Universities of Alberta and Calgary to inform the drafting of these materials.

The new criteria for access and process for obtaining access are available at: http://www.albertahealthservices.ca/8594.asp         

To see AHS memo on Accessing Information from the Alberta Netcare Portal (ANP) for Research Purposes click here.

http://www.albertahealthservices.ca/research/page8594.aspx

Data & Health Information Resources

When Planning Your Study: Identify Your Data Source(s)

Research Facilitation offers consultation to determine data sources most suited to your research questions. To learn more about the availability of AHS data sources for research contact Research.Facilitation@ahs.ca.
For information on criteria and procedures for accessing data for research, contact Research.Administration@ahs.ca.

When Conducting Your Study

Research Ethics Boards (REBs) and AHS, as data custodians, have different responsibilities under the Health Information Act when health information is requested for use and disclosure for clinical research purposes.
As custodians of health information, AHS must evaluate applications for data for studies approved by Research Ethics Boards (REBs) prior to disclosing health information, performing data matching or any other services requested to facilitate the research project.
If the custodian decides to support the research as requested, the custodian must impose the conditions suggested by the REB and enter into an HIA Research Agreement in which the researcher agrees to:
  1. Comply with HIA regulations;
  2. Any conditions imposed by the custodian relating to the use, protection, disclosure, return or disposal of the health information; and
  3. Any requirement imposed by the custodian to provide safeguards against the identification, direct or indirect, of an individual who is the subject of the health information. This can even include requiring consent (even if the REB has waived it) if the information is particularly sensitive.
The most common forms to access data include:
  • Data Extraction
  • Paper Charts
  • Direct System Access (Including Alberta Netcare Portal)


Data can often be extracted and linked for research purposes from AHS clinical and corporate systems.
If you require assistance in identifying appropriate data source(s) for your research project and for information about AHS Data Reporting Repository (AHSDRR), please contact Research.Facilitation@ahs.ca.
Research Facilitation provides data extraction and linkage services from AHS Administrative Data Sources for most Research Ethics Board approved projects free of charge. Charges may apply to highly complex projects and industry-funded research. Services include:
  • Refine research question to make it suitable for analysis using administrative data sources
  • Identify appropriate administrative data sources
  • Identify and operationalize cohorts using administrative data
  • Identify and operationalize outcome measures
  • Identify and operationalize covariates and confounding factors
  • Prepare a data acquisition plan that describes steps to take in acquiring data


 
What sort of 

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