Wednesday, May 26, 2010

HIT Policy Committee - Encryption Mandate is either misguided or misunderstood

Last week the HIT Policy declared that Encryption was necessary in NHIN-Direct. This was reported in many forums: Government Health IT, Health Data Management, iHealthBeat, Federal Computer Week, etc. But in all of these cases there is little discussion of the potential unintended consequences of this 'policy' decision.

The following comes from the presentation given at that committee meeting (Slides 6 and 7)
  1. We need specific policies, as well as technology requirements, to govern all forms of electronic health information exchange.
    • Implement the Nationwide Privacy and Security Framework principles.
    • Work should take place ideally before, or at least in conjunction with, technology standards work.
      • Technology should implement policy and not make it
    • Fill gaps in current law.
    • Address “facilitator” access to identifiable information
      • Constraints on collection, access, and use of identifiable data
      • Constraints on data retention and re-use 
      • Security requirements
  2. One-to-one exchange from one provider to another for treatment purposes – even with no “facilitator” - must be governed by policies that at least include:
    • Encryption (no ability for facilitator to access content) 
      • Encryption ideally should be required when potential for transmitted data to be exposed (mandate through meaningful use/certification criteria or HIPAA security rule modification) 
    • Limits on identifiable (or potentially identifiable) information in the message 
    • Identification and authentication 
  3. If strong policies such as the above are in place and enforced, we don’t think the above scenario needs any additional individual consent beyond what is already required by current law.
So, this has been taken by some inside the NHIN-Direct project as a mandate for end-to-end encryption and the forbidding of any intermediary. There is evidence on Slide 8 that the HIT Policy committee really is worried about intermediaries, as they continue on to explain that their is concern that regulations are not covering these Business Associates. I believe that this is not true anymore. The HITECH Act did update this.

More importantly the HIT Policy committee should be defining policies that bring the Health Information Exchange (HIE) 'into' control. They are rather telling the standards committees to make sure that the HIE is kept 'out' of the conversation. This is a miss-guided policy, even if it is the easy policy statement.

When this 'facilitator' is indeed only 'routing' the information it is surely possible that they only need to have access to the information necessary to 'route'.  Those that read my blog will recognize that when using Mutually-Authenticated-TLS with Encryption/Hashing; that all of the Internet IP-Routers will only have access to the necessary IP-Addresses to route the communications from the Source to the Destination. In this case one can surely understand that this meets the requirement.  I have been very careful to always indicate that in this case the 'routing' and 'Address' are at the IP level. When communicating in a point-to-point way between these two endpoints TLS works wonderful.

Some within NHIN-Direct are looking at what NHIN-Direct defined as a NHIN 'Address'. In this case an address includes more than the IP-Address, but also includes the target user/group/process. The NHIN Address looks very much like an e-Mail Address, and it is possible that it is indeed an e-Mail Address.

There some in NHIN-Direct that want to use e-Mail as the transport, and thus the whole NHIN-Direct Address would need to be 'known' by the e-Mail infrastructure (aka 'facilitator'). They could isolate their e-Mail infrastructure with TLS, but they would like to potentially use the 'Internet' e-Mail infrastructure. The advantage of using the 'Internet' e-Mail infrastructure is that it already exists and is very common and well understood by many. When they use the e-Mail infrastructure they thus are bringing in 'facilitators' that need to see the NHIN-Direct Address, but clearly don't need to see the contents. The e-Mail architects would logically use Message level security to satisfy the requirement. There is two solutions here: S/MIME and PGP. These two solutions have benefits and drawbacks that make them about equal but not compatible.

When using a point-to-point protocol, such as HTTP or SOAP, there is no need to expose this additional part of the NHIN 'Address' to the 'IP-Routing'. So, these architects are pushing this NHIN-Direct Address inside the TLS envelop. Note that in the case of SOAP there is the possibility to use WS-Security to enable message level security, but the community of architects recognize that message level security is today very immature and more burdensome. So for simplicity sake we start with TLS knowing that operationally message level security could be used as the technology and infrastructures mature.


All that said, there is an very large elephant in the room. That is that there is very legitimate reasons why a 'facilitator' might need to see the contents. This need would clearly need to be 'authorized' by the endpoints. This 'authorization' would be based on the fact that the 'facilitator' truly does need to see the content. It is this point that the HIE-Policy committee seems to have missed, or chosen to ignore. It is very possible that the HIT-Policy committee is explicitly recognizing this use-case and explicitly forbidding it. I hope that this is not the case as not all Providers or other NHIN-Direct endpoints are equally enabled. Some Providers really will need 'facilitators' to add value to the communications. This value might be in packaging, distribution, reformatting, archiving, etc.


The HIT-Policy committee needs to recognize that some 'facilitators' should be allowed to be 'authorized' to see the contents of the transactions because they explicitly do add value to the exchange.

Tuesday, May 25, 2010

IHE IT Infrastructure Technical Framework Supplements available for Public Comment

The Public Comment period is now open on the new set of supplements from IHE ITI. Please review and provide critical and constructive comments. The comments are due before June 24

The XUA profile has been updated with a few use-cases where we found mature standards and production interest in using these capabilities. There are a larger set of use-cases that we looked at satisfying, but found either no interest from production environments or not sufficiently mature standards. The hope is that over time there will be more demand for these use-cases and there will be more experimentation with the available standards. Once these use-cases mature we will address them. For those that are implementing these unaddressed use-cases now, please let us know. If we have sufficient evidence of a production need and mature standards then we can roll these use-cases into the post Public Comment phase.

The IHE IT Infrastructure (ITI) Technical Committee has published the following supplements to the ITI Technical Framework for Public Comment:
  • Cross-Enterprise User Assertion - Attribute Extension (XUA++)
  • Deferred Document and Dynamically Created Content (D3S)
  • Healthcare Provider Directory (HPD)
  • Query Enhancements to Sharing Value Sets
The documents are available for download at http://www.ihe.net/Technical_Framework/public_comment.cfm. Comments should be submitted by June 24 to the online forums at http://forums.rsna.org/forumdisplay.php?f=198.

Monday, May 24, 2010

NHIN-Direct Focus and Scope Creep

Keith got lots of feathers ruffled today with his blog Governance, SDOs, PEOs and NHIN Direct , primary because he poked at how unlike a standard the current NHIN-Direct distraction is. My comment to his blog was that the intentions are good, but like all projects it is suffering from scope creep.
Glen put his finger on it. The project is unabashedly a prototype project. It makes no pretense of being a standards organization or a profiling organization. It is trying to re-use existing standards to solve a problem that the small provider has little time to focus on. We should view it more as a consulting gig to all the very small doctor offices, and less like a design-for-all project.

As long as the focus stays on helping the very little provider solve this problem, I believe that it will be useful. But as soon as use-cases that are not specific to the very small doctor office creep in, it will have 'jumped the shark'. (like CCHIT and HITSP before it) Scope-creep will eventually kill it as a useful thing. 
And like clock work an email storm today tries to expand the scope of NHIN-Direct to support individual patients sitting in their home using nothing but an email client. There was much discussion of patients being allowed to invent their own NHIN-Direct 'Addresses'. This 'Address' looks very much like an email address, and in a few months when NHIN-Direct is done prototyping and ultimately chooses the one or two specifications to go forward with it might just be an email address. But the discussion nonetheless continues to discuss the use-case exactly as a patient using a common email service.

At this point I couldn't take it anymore and respond with:

Reality check... We need to focus on the NHIN-Direct prioritized Use-cases and focus on solutions that best fit the very small doctor office with 5 or less doctors. We can't be blind to the other potential use-cases, but we also can't be blind to the other realities.

At the face-to-face meeting it was made very clear that:
a) There is no reason why a Healthcare Provider can't send email to a patient today.
b) There is no reason why a Healthcare Provider can't send attachments in the email today.
c) There is no legal reason to secure these communications as long as the Healthcare Provider has reasonable assurances that the address they are sending is the one the patient told them to send it to.

At least that is what I heard (I think from Devon McGraw ).

In addition: Consumer grade email services do NOT support S/MIME or PGP. Yes I know that there are some, but they are not the big guys. Yes I know that one can get add-on packages, or clients. But I assert that they are impossible for the 'common' patient to use, especially those most in need of healthcare. If a patient does know how to set it up, they are free to convince their Provider to use that system. But most importantly, see above. There is no need to confuse patients or providers on this topic.

Now back into the NHIN-Direct use-cases, where the patient is using a PHR like 'service' that is a common service with many other patients; There is a reason to bring in the NHIN-Direct pre-conditions, transaction requirements, and content packaging. The reason is that the PHR is a 'service' that is offered by an 'organization'.

And on this topic, our current specifications do not get in the way of the patient having one or thousands of addresses, or using individual or group endpoints, or even acting as their own organization. The limiting factor will be the willingness of their Healthcare Providing organizations to scale.

Once we are talking 'scale', we should really be discussing Health Exchanges with support for a longitudinal record (e.g. XDS, or NHIN-Exchange). This can be hosted by the patients' PHR or federated by all their providers or both. This is what HealthVault is already doing, providing a longitudinal exchange platform. This is what many HIE projects within the states are doing. See "Where in the World is CDA and XDS".
A full scale health exchange includes policies (See DURSA). A full scale health exchange includes support for policy bridging including handling of consent and authorization. A full scale health exchange includes organization/entity identification and authentication systems (CA and Revocation checking). A full scale health exchange includes support for security audit logging which can feed an accounting of disclosures report. A full scale health exchange has patient identification and patient discovery mechanisms. A full scale exchange includes methods of data segmentation (aka confidentiality coding). Etc... This scale is NOT the focus of NHIN-Direct.

Reality, NHIN-Direct has prioritized use-cases and a focus to support the small Provider office of 5 doctors or less. Yes this means that they will be talking to larger organizations, but the priority for the solution space preference should be "what is best for the small Provider Office".

Tuesday, May 18, 2010

Accountability using ATNA Audit Controls

As one of the small number of individuals involved in the creation of the IHE Audit Trail and Node Authentication (ATNA) Profile, I am excited to see a vision coming to life. There are those that see the Access Controls as being the tool used to control fine details, this is much harder to do in healthcare give the fluidity of workflows, variability of data, and critical to safety. Thus an Accountability model that leverages Audit Controls are more often used in healthcare. The Audit Controls model supports just as detailed of Policies, but they are enforced using professional ethics and audit log analysis. There are still course Access Controls that keep out those that should never be given access, but those that might need access are given access rights. Along with this is strong training on the policy informing the users that they are under. When using Audit Controls to enforce Accountability there is much more reliance on good behavior enforced through swift punishment as said in an article this week Train Employees Not To Snoop; Fire Those Who Do. This Audit Controls model is not critical to the success of ATNA, but the success of the ATNA audit log is critical to the success of an Audit Control model.

At the time we wrote ATNA we knew that the vendors involved in Healthcare software and medical-devices are experts in; healthcare software and medical devices; and were quite bad at security. This holds true today, although it is getting better. What we wanted to do was leverage existing security infrastructure and keep those developers focused on great healthcare software and medical-devices. This is shown through not just IHE ATNA, but alsoConsistent Time Profile, Document Digital Signature Content Profile, Enterprise User Authentication Profile, Personnel White Pages Profile, Cross-Enterprise User Assertion Profile and to a lesser extent Basic Patient Privacy Consents Profile. All of these profiles tried to invent as little as possible, tried to use as little specialization for healthcare, and use as much of existing and mature IT.


Even within IHE ATNA there are many threads that are exciting to see continue to be a strong force today (like: Mutually-Authenticated-TLS, and Federated Access Controls at the edges). The specific topic of this article is the Audit Logging functionality. As stated above, the healthcare software of the time was really good with algorithms but not good at all at figuring out how to make something useful out of a security event log. At the same time there was an IT industry that was getting quite good at analyzing firewall logs, intrusion-detection logs, database health logs, hard-drive failure logs, etc. We figured that by letting the healthcare software developers focus on developing great healthcare software, and letting audit-log analyzing developers spend their time analyzing audit logs; that we had the helped both groups out.

It was not a smooth path. We tried to find a standards organization that was interested in developing a security audit log message that would meet healthcare's needs for security-surveillance. The usual set of standards organizations for healthcare (HL7, DICOM, ISO, and ASTM) did not think that they were the right place to develop the standard. So, off we went to a neutral third party, IETF. At the time they would allow anyone with interested parties develop a standard. We started with ASTM-E2147-01 "Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems". Through much difficulty, mostly due to growing pains in IETF, we produced RFC-3881. The problem was that IETF rules forced us to keep it 'informative', ok we could have gone through the pain but we found that DICOM would make the schema normative as part of specializing it for DICOM purposes. We then could reference this normative specification in IHE and produce ATNA.


All we needed was a normative transport, which was many more years of struggle. We pointed to the BSD-SYSLOG specification that captured what most everyone was doing with UDP. We pointed to Reliable-SYSLOG, as a freshly minted IETF standard that seemed to have all the right characteristics. Well Reliable-SYSLOG failed in the market, it was too difficult and was not perceived as being worth the extra trouble. We pushed the SYSLOG community to please give us normative specifications and a specification for what most all systems were doing with TCP rather than UDP. Many years later we now have SYSLOG-Protocol, and a binding for UDP and TCP. Even that couldn't be easy as IETF rules forced some unfortunate things.

Along the way, NIST SP800-92 Guide to Computer Security Log Management would all but endorse our model even if they didn't know of IHE-ATNA.  All of the above specifications are really still moving ever so slightly, but are mostly well established. The most interesting development is one in HL7, where a 'service' is being defined specifically for 'accounting of disclosures'. As part of this project we are defining what a audit log event for a disclosure would look like if one knew all the possible attributes (who, what, when, where, why....). This might be an academic exercise, but will give us room to build audit log analysis on. The ATNA can inform an Accounting of Disclosures.

So through all of this growing pain we have tried hard to show at the HIMSS Interoperability Showcase what an audit log repository would look like. It has never really been too exciting, and mostly we must show off incomplete applications. However through much of this I am seeing at least two vendors fighting hard to make the audit log analysis a highly valuable tool. HIPAAT has been in the trenches with us for some time, and I have also encouraged FairWarning. Any others that are out there are welcome to post a comment to this article.

The good news is that we continue to see that audit log analysis does work to detect and convict those that would abuse their access rights against policy. It is important to not just have technology but to use the technology securely.

Monday, May 17, 2010

Much said lately about Security/Privacy, but really nothing new

There was lots of healthcare related privacy and security news last week, but ultimately not much new was said.
All have the same theme. There is now a forcing function in OCR and their Breach Notification web site. It is time to dust off the Risk Assessment tools, Document what you do, and do what you document. To emphasize this, OCR released today Security Rule Draft Guidance
The Office for Civil Rights (OCR) is responsible for issuing periodic guidance on the provisions in the HIPAA Security Rule. (45 C.F.R. §§ 164.302 – 318.)  This series of guidance documents will assist organizations in identifying and implementing the most effective and appropriate administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic protected health information. The materials will be updated annually, as appropriate.
Yes, nothing new… Well, what is new is a market place realization that they just might need to take security and privacy seriously.

Friday, May 14, 2010

Re: Personal Health Records May Not Be So Personal

When I saw the "Personal Health Records May Not Be So Personal" article I had high hopes at the level of detail they went into. But I was simply disappointed at the lack of detail in the article. I guess and hope that the detail in their actual research is more complete. Their first failing is that they only looked at 'tethered-PHR', explicitly excluding standalone PHR. A tethered-PHR is when a patient is given some form of access into their doctors EHR. This is not the same as a standalone PHR that has multiple data sources and other value. A tethered-PHR has only access to the information that the one EHR provides. This is not a bad functionality, but when it comes to the topic they wanted to investigate it is too limiting.

Overall, the PHR concept itself needs some major maturity. Until more patients try it out and many iterations happen the concept of what a PHR should be is still very 'alpha'. I did like the list of PHR features that they identified. The very small number of people using a PHR (7%) are a vocal minority that are truly interested in participating in the management of their data. I have played around with my provider's Tethered-PHR, and the other standalone PHR. I am motivated to try these tools, but I must simply not be sick enough to get any value out of these tools (not that I am complaining).
Researchers assessed the following 10 PHR policies at each organization:
  • Patient proxies enable PHR access;
  • PHR access for minors;
  • Patient views of electronic health record clinical notes;
  • Patient views of EHR diagnosis list;
  • Patient control of information access;
  • Research using self-entered data;
  • Third-party PHR Web advertising;
  • Emergency, "break the glass" access;
  • Normal lab results PHR availability; and
  • Clinical response to patient e-mails.

I would like to respond to a specific thing that was said:
Reti [Shane Reti -- an author of the report and a physician at Beth Israel Deaconess Medical Center] noted that other commercial PHR products, such as Google Health and Microsoft HealthVault, actually lead the field when it comes to patient-centered functions. He said that because such firms are not considered covered entities under HIPAA, they are not bound by the same privacy and security regulations. Reti said that Google and Microsoft still comply with HIPAA regulations, but they "are able to be more creative and move quicker because they don't require the same sign offs and double checks of HIPAA." More
This is NOT so much because they are 'covered entities', as that they are a healthcare provider and are bound by 'Medical Records Regulations'.This does not change the rational that Google Health and Microsoft Healthvault can move faster because they likely don't have as many 'sign offs and double checks'. I am just pointing out that these sign offs and double checks are far more likely a reaction to medical records and torte law. Of course, the standalone PHR vendors will eventually do something stupid, and will over time add checks and double checks. They simply are less burdened by the costs of their mistakes.

Thursday, May 13, 2010

FYI: NHIN University - The Trust Fabric of the NHIN

NHIN University to Discuss Issues of Trust in Nationwide Health Information Exchange
In February, the NHIN Workgroup of the HIT Policy Committee recommended to the National Coordinator for Health IT that it is the role of the government to "establish and maintain a framework of trust, including ensuring adequate privacy and security protections to enable electronic health information exchange."

On Monday, May 24, 2010, experts in the development of this and other trust frameworks will serve as faculty for NHIN University's NHIN 104 - The Trust Fabric of the NHIN: Making Exchange a Good Choice.  In this free 1.5 hour online class, students will have an opportunity to talk with these experts about how issues of trust between health information exchange participants are being addressed in the context of the Nationwide Health Information Network.  By participating in this class, students will become familiar with:

  • Key components of trust and why they are important
  • How the NHIN Exchange trust fabric maps to the key trust components
  • Efforts to harmonize the NHIN Exchange trust components with the rest of the NHIN ecosystem, including state-level HIEs and the NHIN Direct program


NHIN 104 - The Trust Fabric of the NHIN: Making Exchange a Good Choice
DATE: Monday, May 24, 2010 (add to your calendar)           TIME: 1:00 - 2:30 pm ET
FACULTY: 
  • Mariann Yeager - NHIN Policy & Governance Lead (Contractor), Office of the National Coordinator for Health IT (ONC)
  • Steve Gravely, JD - Troutman Sanders LLP
WEBINAR:  https://nationalehealthevents.webex.com/nationalehealthevents/onstage/g.php?d=665403498&t=a

AUDIOCONFERENCE:  (866) 699-3239 or (408) 792-6300
(Please join the event with a computer system first and follow the audio instructions on the screen.)

ACCESS/EVENT CODE: 665 403 498

ATTENDEE ID: You will receive this number when you join the event first with a computer connection.

READ THE NHIN 104 COURSE DESCRIPTION AND LEARNING OBJECTIVES


 NHIN 105: The Future Landscape will be offered in mid-June.  Watch for details!

Review the full Spring Semester Course Catalog: www.NationaleHealth.org/NHIN-U