[Openid-specs-heart] HEART Clinical Research UMA

Glen Marshall [SRS] gfm at securityrs.com
Sun Jan 24 02:13:30 UTC 2016


Aaron,

As is typical for use cases, peripheral items in the problem statement 
narrative add 'color' to make the scenario life-like.  The technical 
solutions later in the use case do not depend on them.

Best,
Glen

*Glen F. Marshall*
Consultant
Security Risk Solutions, Inc.
698 Fishermans Bend
Mount Pleasant, SC 29464
Tel: (610) 644-2452
Mobile: (610) 613-3084
gfm at securityrs.com
www.SecurityRiskSolutions.com

On 1/23/16 20:07, Aaron Seib, NATE wrote:
>
> What does peripheral mean?  For decoration purposes only? Seems to 
> introduce noise and take away from what you are trying to convey is my 
> point.
>
> Aaron Seib, CEO
>
> @CaptBlueButton
>
>  (o) 301-540-2311
>
> (m) 301-326-6843
>
> cid:image001.jpg at 01D10761.5BE2FE00 <nate-trust.org>
>
> *From:*Glen Marshall [SRS] [mailto:gfm at securityrs.com]
> *Sent:* Saturday, January 23, 2016 8:03 PM
> *To:* Aaron Seib, NATE; HEART List
> *Subject:* Re: [Openid-specs-heart] HEART Clinical Research UMA
>
> Aaron,
>
> In response to your comments on the use case narrative:
>
>   * All of the data including the genomic data?  It will be made
>     available to whom?
>       o The use case is for clinical data collected and made available
>         to the clinical researchers for the study.  The nature of the
>         data, e.g., genomics and other clinical results, is peripheral.
>
> I don’t know that there is a way to pseudonymize Genomic data is the 
> point I was trying to make.  It is a real issue – I was trying to 
> suggest it is not peripheral as a result.  If it is peripheral I would 
> remove the reference to gemonics all together.
>
>   * How will her genome be pseudonymized?
>       o The specific pseudonymization (and re-identification)
>         algorithms are likely to be specific to the clinical research
>         study, informed by the cited standards.
>   * If they can access her PHR why do they need to access the EMR as
>     well?   Isn't the point of HEART that she have a complete record
>     of all of her data in the PHR.   What is in the EHR that is
>     missing from the PHR?  Why?
>       o I have assumed the current state of data sharing among EHRs
>         and PHRs.  It is peripheral to the use case.
>   * This is a transitional use case that will hopefully go away one
>     day.  It may be necessary for now if there is data in the EHR that
>     isn't transportable to the PHR but I would hope that the day will
>     come when we aren't treating the Clinical Operations software as
>     the only source that inputs to the researchers data warehouse can
>     be populated.  I would argue that PHR's will have more complete
>     data then the two EMRs as the EMRs will lack the PGHD that could
>     more readily be gathered via the PHR in comparison to forcing it
>     to fit into the EMR of the Oncologist.
>       o There are multiple EHRs in this use case and, while I'd like
>         all EHRs and PHRs to be interoperable, they are not
>         presently.  This is peripheral to the use case.
>   * Am I missing something important.  Why is the patient only able to
>     get a summary of the data?
>       o This references reports of disclosures from the EHRs to the
>         CDRN.  A disclosure report for each transmission to the CDRN
>         is assumed, and that may reference multiple data sets in
>         summary.  The actual content and frequency of reports is not
>         standardized, and is influenced by policy outside of the use
>         case.  This is peripheral to the use case.
>   * [In reference to pharma's offer of a continuing access agreement
>     and profit-sharing.]  Has this ever happened?  Is there anyone
>     (from Pharma) proposing that they will do this?
>       o That is my hypothetical resolution to the issue of subsequent
>         re-use of Alice's data.  That might have been a more
>         satisfying resolution to the Henrietta Lacks case.  The actual
>         resolution is peripheral to the use case.
>
> Best,
> Glen
>
> *Glen F. Marshall*
> Consultant
> Security Risk Solutions, Inc.
> 698 Fishermans Bend
> Mount Pleasant, SC 29464
> Tel: (610) 644-2452
> Mobile: (610) 613-3084
> gfm at securityrs.com <mailto:gfm at securityrs.com>
> www.SecurityRiskSolutions.com <http://www.SecurityRiskSolutions.com>
>
> On 1/23/16 18:39, Aaron Seib, NATE wrote:
>
>     Glen – I had a lot of questions that I captured as comments in the
>     attached.
>
>     Aaron Seib, CEO
>
>     @CaptBlueButton
>
>      (o) 301-540-2311
>
>     (m) 301-326-6843
>
>     cid:image001.jpg at 01D10761.5BE2FE00 <nate-trust.org>
>
>     *From:*Openid-specs-heart
>     [mailto:openid-specs-heart-bounces at lists.openid.net] *On Behalf Of
>     *Glen Marshall [SRS]
>     *Sent:* Saturday, January 23, 2016 12:58 PM
>     *To:* Sarah Squire
>     *Cc:* HEART List
>     *Subject:* Re: [Openid-specs-heart] HEART Clinical Research UMA
>
>     Gladly!  See attached PDF.
>
>     *Glen F. Marshall*
>     Consultant
>     Security Risk Solutions, Inc.
>     698 Fishermans Bend
>     Mount Pleasant, SC 29464
>     Tel: (610) 644-2452
>     Mobile: (610) 613-3084
>     gfm at securityrs.com <mailto:gfm at securityrs.com>
>     www.SecurityRiskSolutions.com <http://www.SecurityRiskSolutions.com>
>
>     On 1/23/16 12:53, Sarah Squire wrote:
>
>         Hi Glen,
>
>         Your sharepoint link isn't working. Could you send a pdf to
>         the list please?
>
>         Thanks,
>
>         Sarah
>
>
>         Sarah Squire
>
>         Engage Identity
>
>         http://engageidentity.com
>
>         On Fri, Jan 22, 2016 at 2:55 PM, Glen F. Marshall
>         <glen.f.marshall at gmail.com <mailto:glen.f.marshall at gmail.com>>
>         wrote:
>
>         Team,
>
>         Here is a *link
>         <https://srsmail-my.sharepoint.com/personal/gfm_securityrs_com/_layouts/15/guestaccess.aspx?guestaccesstoken=2QxXSnxuijrIbiElNuU%2bCJIV0G6FBK5uWbdt0FvvVFg%3d&docid=2_1c5c33062f8ee4dbe9dbf61ba9524ca39>*
>         to a read-only shared copy of the updated Clinical Research
>         (UMA) use case.  It now contains fleshed-out business
>         prerequisites, sequence diagrams, and some minor corrections.
>
>         Please respond with your suggestions, corrections, etc.  But
>         please do not alter the document itself, as the master Word
>         copy and Visio graphics are all in my personal cloud storage.
>
>         Note I have not included the final sequence diagram -- review
>         of disclosures and modification of UMA permissions -- as I'd
>         like to discuss the proper UMA mechanisms and flow to
>         accomplish the modifications.
>
>         Also note I have specifically made the AS a singular
>         IRB-selected element within the use case.  All access control
>         policies are determined by the IRB for ongoing access, with
>         the patient consenting to them.  This also keeps HEART away
>         from ongoing political, regulatory, and policy matters that
>         are properly out of scope for our technical work.
>
>         Since I will be at the IHE Connectathon next week, I won't be
>         on our schedule 1/25 call.  Looking forward to discussions
>         on-list and in February meetings.
>
>         Best,
>         Glen
>
>
>
>         _______________________________________________
>         Openid-specs-heart mailing list
>         Openid-specs-heart at lists.openid.net
>         <mailto:Openid-specs-heart at lists.openid.net>
>         http://lists.openid.net/mailman/listinfo/openid-specs-heart
>

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