[Openid-specs-heart] HEART 2015-08-05 meeting notes

Thu Aug 6 13:28:23 UTC 2015

Adrian,

This is very specifically my point… We, in HEART, acknowledge the problem and place it clearly as a pre-condition. There is much value we can add within this context, and little we can do about this problem. 

John

From: agropper at gmail.com [mailto:agropper at gmail.com] On Behalf Of Adrian Gropper
Sent: Thursday, August 06, 2015 8:16 AM
To: Moehrke, John (GE Healthcare)
Cc: Debbie Bucci; openid-specs-heart at lists.openid.net; James Hazard
Subject: Re: [Openid-specs-heart] HEART 2015-08-05 meeting notes

John is right. Debbie is right too. We did spend many months discussing consent with the VA during Privacy on FHIR. We used DS4P (Data Segmentation for Privacy). Justin was there and I hope he will now chip into this discussion with his joyous experience. Here we go again...

Consent, in the sense that John is using it is easiest to see with state health information exchanges (HIE) like the one I'm involved with in Massachusetts. I can provide much detail and color on how that evolved over two years. In my opinion, it's legal quicksand - but that only excites the institutional legal concerns that the VA and other Covered Entities (CE) live to deal with. I've had help from a real lawyer in working on some of this so I've cc'd Jim to this thread.

What the CEs seek is a safe harbor. What the CEs want to avoid is transparency. When HIPAA took away the right of consent in 2002, they introduced accountability in the form of Accounting for Disclosures (A4D). If you have consent without A4D, the only way privacy breaches become known is from whistle blowers and, as we see so often today, even security breaches are not discovered for months. The CEs have steadfastly refused to implement A4D as digital real-time notice because "it's too hard". The result is a privacy and security mess in healthcare that we don't see in finance or commerce.

Let me get to the point:

Consent, including for DS4P or HIE, implies a choice on the part of the subject. This choice can be represented by a form just like the ROI form (I've attached the correct annotated PDF. The one I uploaded before was corrupt.) The only difference is how the Client is specified in section 3 and whether the patient is aware that their information has just been transferred from 1 to 3.

After months of PoF and two dozen days of furious discussion about "consent", "consent directives", institutional, state, and federal jurisdictional restrictions,....... the matter still comes down to one or more forms just like the ROI form and whether or not the Resource Server is responsible for contemporaneous notification to the subject that their data was sent from 1 to 3.

As far as the "paper trail" the lawyers would prefer around this ROI form, this is Jim's specialty but from where I stand it is absolutely nothing specific to healthcare and would be much better dealt with in OpenID or IDESG than in HL7.

Adrian

On Thu, Aug 6, 2015 at 8:38 AM, Moehrke, John (GE Healthcare) <John.Moehrke at med.ge.com> wrote:

Debbie,

Yes, that is what I am proposing that we Assert. That there is some legally defendable ceremony that is done that gives assurance to all parties involved. But that this is a gross ceremony. The fine-grain, actual authorization, is done inside technology (UMA/OAuth). In this way the Covered Entities get their legal bases covered, while everyone gets a more dynamic solution for day-to-day, or activity-by-activity from HEART.

John

From: Debbie Bucci [mailto:debbucci at gmail.com] 
Sent: Thursday, August 06, 2015 7:30 AM
To: Moehrke, John (GE Healthcare)
Cc: openid-specs-heart at lists.openid.net; Adrian Gropper
Subject: RE: [Openid-specs-heart] HEART 2015-08-05 meeting notes

I know I am generalizing  but this flow augments or runs parallel to the opt-in/opt-out options I have seen for release of personal identifying information or the options I am forced to acknowledge when installing/initializing/registering/ authenticating to an app for the first time .   

Asynchrously identifying these sort of preferences moves us towards the more complicated DS4P UMA like scenarios (PoF)

On Aug 6, 2015 7:27 AM, "Moehrke, John (GE Healthcare)" <John.Moehrke at med.ge.com> wrote:

At the federal level, under HIPAA alone, there is no need for consent for purposes of using the data within the Covered Entity for Treatment, Payment, and Normal operations.

BUT, there are plenty of states that require consent… Ignoring reality of states regulations is not useful.

AND, there are some institutions that would rather have a consent that authorizes them to share beyond their Covered Entity boundary. Not everyone reads HIPAA ‘Treatment’ as an authorization to share with any treating provider.

AND, there are some ‘sensitive’ health topics covered by federal money that do come with a requirement for consent for sharing. This was the main focus of the DS4P efforts.

So, let’s not focus on HIPAA alone. Let’s expect that ‘for whatever reason an organization wants to have positive evidence that the patient desires sharing to happen’ as the trigger to allow it to happen (otherwise deny it from happening. This would seem more helpful to the community we are doing this work for. 

An important aspect of all of this is how will the organization holding the data be able to legally defend that a UMA/OAuth token was valid evidence of consent that would hold up in a courtroom… We can’t address this in HEART, but it should not slow us down. We again, document this as a precondition to our work. One way this is done is that a paper trail is a part of the initial setup of a patient engaging with the system.

John

From: Openid-specs-heart [mailto:openid-specs-heart-bounces at lists.openid.net] On Behalf Of Adrian Gropper
Sent: Wednesday, August 05, 2015 11:49 PM
To: Debbie Bucci
Cc: openid-specs-heart at lists.openid.net
Subject: Re: [Openid-specs-heart] HEART 2015-08-05 meeting notes

I have never heard the term "simple consent". There's nothing like "consent" in the context of data sharing that I can think of. HIPAA removed the patient's right of consent in 2002 https://patientprivacyrights.org/?s=HIPAA+Consent <https://urldefense.proofpoint.com/v2/url?u=https-3A__patientprivacyrights.org_-3Fs-3DHIPAA-2BConsent&d=AwMFaQ&c=IV_clAzoPDE253xZdHuilRgztyh_RiV3wUrLrDQYWSI&r=B4hg7NQHul-cxfpT_e9Lh49ujUftqzJ6q17C2t3eI64&m=QPfpP6tNPhNn0uCYFnfBuRqSH5IVEwKw_Jqp3j4NGRQ&s=u1OCcH7ZkX-4jzmNs_eIhVZUi0lQOy0npXd30zYGE8I&e=> 

There are consent forms for research but that's not part of the use cases we're tackling these days.

Does anyone have an example of consent for clinical data sharing to share with us?

Adrian

On Thu, Aug 6, 2015 at 12:10 AM, Debbie Bucci <debbucci at gmail.com> wrote:

@Eve - yes I know its client but I'm really hung up on the token generation/choices.   Thanks for the tweaks.

I know we clarified that the release form is NOT consent in one of our earlier meetings  but is this (release of information) what I have heard others refer to as simple consent?    During this process would access to problems/meds/allergies be included in that authorization/consent flow?    I visualized more than demographics in the conversation.

On Wed, Aug 5, 2015 at 9:21 PM, Justin Richer <jricher at mit.edu> wrote:

Thank you, Adrian, this is a great reference! I think your annotations make sense as well, things should map pretty plainly to the OAuth process. The tricky part (that we got a start on today) is going to be the scopes bits and getting those right.

For an UMA flow, it's also similar, except that the "who can see it" is a set of claims instead of the client application.

 -- Justin

On 8/5/2015 9:12 PM, Adrian Gropper wrote:

I've attached a very typical Release of Information authorization. I've annotated the 5 elements common to all such documents that I have ever seen. The stuff outside if the rectangles is more or less optional. 

This form covers one direction of the EHR-PHR Use Case. It is presented to the Custodian (the patient or their designate ) and approved by them by the Resource Server and pre-filled with information supplied by the Client, if available. 

In some cases, the Client information is not available at the time the Authorization form is signed. In that case, it will be up to the Authorization Server to consider the Client and User information and provide the authorization to the Resource Server.

The Resource Server has the final say in all cases and could decide to ignore the authorization based on local or jurisdictional policy. This is outside the control of the Resource Owner and likely to be out of scope for HEART in all use-cases.

This ROI Authorization Form is the only "consent" that I'm aware of in clinical IT. Patients are asked to sign other documents, including:

Registration Form, Notice of Privacy Practices, and Treatment Consent but none of these has anything to do with sharing of health data (except for HIPAA TPO which we will not get into here.)

Adrian

On Wed, Aug 5, 2015 at 8:27 PM, jim kragh <kragh65 at gmail.com> wrote:

Thanks for sharing,...  informative and constructive in reaching the patient end point. 

May all have a nice evening!

On Wed, Aug 5, 2015 at 3:26 PM, Debbie Bucci <debbucci at gmail.com> wrote:

Attendees:

Eve Maler

Justin Richer

Josh Mandel

Adrian Gropper

Thomas Sullivan 

Debbie Bucci

We have decided to delineate between mechanical and semantic scope docs.

For the PCP <-> PHR use case:

The pre determined choice token confidential token choice and exactly what information needs (example: PHR's authorization endpoint)  to be shared in advance between the PCP's EHR and Alice's PCP was left out of the discussion for now.

There is one basic mechanical Oauth  generic flow that occurs twice in the use case.

Given the group has generally agreed that the SMART specifications are a good place to start ... for this particular use case  the only semantic FHIR scope that is necessary is the patient/*.read scope that grants permission to read any resource for the current patient.

During the registration process Alice should be able to select at a fine grain level which resources she is willing to share with the PHR.   This mimic's a specific process - Adrian please provide.  This information will be used to generate the access token.

The one thing left at the end of the discussion is whether the patient record is implicit or explicitly stated.  This is a design decision that may make a difference as we move towards our next use case in which delegation is a factor.

Corrections/updates appreciated.   

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-- 

Adrian Gropper MD

RESTORE Health Privacy!
HELP us fight for the right to control personal health data.
DONATE:  <https://urldefense.proofpoint.com/v2/url?u=http-3A__patientprivacyrights.org_donate-2D2_&d=AwMFaQ&c=IV_clAzoPDE253xZdHuilRgztyh_RiV3wUrLrDQYWSI&r=B4hg7NQHul-cxfpT_e9Lh49ujUftqzJ6q17C2t3eI64&m=QPfpP6tNPhNn0uCYFnfBuRqSH5IVEwKw_Jqp3j4NGRQ&s=5EO5dh5y1O7CjbbjqdwxTBcdii8ABtLHO2waj3VDYfw&e=> http://patientprivacyrights.org/donate-2/ 

-- 

Adrian Gropper MD

RESTORE Health Privacy!
HELP us fight for the right to control personal health data.
DONATE:  <https://urldefense.proofpoint.com/v2/url?u=http-3A__patientprivacyrights.org_donate-2D2_&d=AwMFaQ&c=IV_clAzoPDE253xZdHuilRgztyh_RiV3wUrLrDQYWSI&r=B4hg7NQHul-cxfpT_e9Lh49ujUftqzJ6q17C2t3eI64&m=5HHUoKZdMx9Whk72F2s-7NR3Q-9MR0B0Ms-WJwEfJts&s=nOSfTdko8ysZcb_UcftB-yrc7dVK4Vn61e_9mWIZuq8&e=> http://patientprivacyrights.org/donate-2/ 

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