Patient API Access in MU3


We’re in a Meaningful Use Stage 3 comment period!

The Meaningful Use Stage 3 final rule was published on October 16th, and came with a 60-day open comment period. Anyone can submit a comment here.

Patient API access is a critically important MU3 guarantee

I want to share a comment I’ve submitted that deals with a critically important (and strongly worded) guarantee that MU3 provides: a patient’s right to access data through an API, using “any application of their choice”. This is a critical issue because this guarantee would open up data access in a very wide, very real way — but it also comes with a host of security and privacy concerns (as well as business concerns) that will cause provider organizations to push back against it.

Below is my comment, verbatim. I’d love to hear your thoughts @JoshCMandel.

Josh’s Comment on Patient API Access

The following language pertaining to patient access must be be clarified to ensure it retains its intended potency:

The provider ensures the patient’s health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the API in the provider’s CEHRT.

The key question here is: which parties need to agree that an app is (so to speak) “okay to use”?

The regulatory intent appears to support the idea that patients make this decision, choosing among all apps that have been configured to work with the provider’s EHR. But what does it take for an app developer to configure an app to work with the provider’s EHR? Beyond technical details, is it okay for a provider to tell an app developer something like:

1. “Sorry, your app sounds good and useful, but we don’t choose to make it available to our patients.”

2. “Sorry, your app might be useful but it’s duplicitive: we already offer a similar functionality to our patients through another app, or through our own portal.”

3. “Sorry, your app is designed to help patients move away from our practice by seeking a second opinion, and that’s against our business interest.”

4. “Sorry, your app offers what we consider to be questionable clinical advice.”

5. “Sorry, we don’t believe your app will do an adequate job of protecting patient data.”

CMS should clarify that providers may not use these excuses to prohibit apps from becoming available to patients. If a provider can reject apps for policy reasons like the ones described above, this will lead to an environment that fails to provide patients a right to access their data in a useful way.

But of course some of the concerns above are important, especially as they begin to touch on clinical utility and data protection. CMS should clarify that protection comes, ultimately, from allowing patients to make informed decisions about which apps to use. It is reasonable for providers to share warnings, or endorsements, or to ask questions like “Are you sure?” with specific confirmations, or to assign apps to different levels of trust or approval — but a provider must not prohibit a patient from using a specific app (just as they must not refuse to fax a patient’s data to a patient-specified phone number).

One important step in ensuring this kind of access will be clarification about who is responsible for a data breach in the case where a patient has approved an app to access EHR data. The Office for Civil Rights should issue a clear statement that providers are not responsible for what happens downstream, after healthcare data are shared with a patient-selected and patient-authorized app. By analogy, we expect providers to share healthcare information by fax to any phone number that a patient identifies, as long as the patient has authorized the transmission; we should look at sharing data with apps the same way. This kind of clear statement from OCR will be a necessary step to ensure that providers do not perceive conflicting obligations.

OAuth2 for Healthcare: Are we ready?


Last weekend I got an email asking whether OAuth 2.0 is ready to deploy for healthcare. Given SMART’s use on OAuth 2.0, I think so! Here’s the exchange…

The question I received


I realize that the big news is the NPRMs being released, but one thing that I have been interested in is the big push for using OAuth 2.0 with newer standards (primarily FHIR related), and the known vulnerabilities in OAuth2.0.

I realize that HL7’s security Workgroup has experts and the other organizations consult experts (and I’m certainly not questioning the work they have done in this area) , but considering we are talking about healthcare data – it seems that it might have raised at least a few eyebrows and would have been addressed more openly.

Below are just a few links that explain.  I do not know how many – if any – of these vulnerabilities have been resolved since these were printed.

I just thought this was interesting…

My executive summary-level response:

There have been many reports of flawed OAuth 2.0 implementations, but there have not been security vulnerabilities identified in the OAuth 2.0 framework itself.  The community is constantly improving on best practices that help developers avoid implementation pitfalls.  There are already real-world OAuth 2.0 deployments in healthcare.

My more detailed take:

The overall system security of an OAuth 2.0 implementation depends critically on a substantial number of implementation details (as with any reasonably-capable authorization framework). The core OAuth 2.0 spec is accompanied by a “Threat Model and Security Considerations” document (RFC 6819) outlining many risks; and other groups have performed related analyses. The bottom line is that a robust implementation of OAuth 2.0 must account for these risks and ensure that appropriate mitigations are in place.

Sensational headlines in the blogosophere generally identify places where an individual implementer got some of these details wrong. In large measure, we’ve seen so many of these stories simply because OAuth 2.0 is so widely deployed — not because it’s so deeply flawed. (Now, we can argue that a well-designed security protocol should protect implementers from all kinds of mistakes — and that’s fair. But the collective community experience in identifying these threats, learning how things go wrong, memorializing the understanding in clearer recommendations and more-capable reference software implementations is exactly how that protection emerges.) At the end of the day, Microsoft, Google, Facebook, Twitter, Salesforce, and many, many more players (large and small) offer, promote, and continue to expand their OAuth 2.0 deployments.

With respect to health IT, there is ongoing work to define profiles of OAuth 2.0 that promote best practices and avoid common pitfalls. Three examples are:

MITRE’s OAuth 2.0 profiles created for VA:

SMART on FHIR’s profiles for EHR plug-in apps

OpenID Foundation’s Health Relationship Trust (HEART) Workgroup:

Commercial health IT vendors have already deployed OAuth 2.0 implementations, and I expect we’ll see many more in the near future.

Ebola in the United States: EHRs as a Public Health Tool at the Point of Care


screenshot of PDF

What if, in the midst of a crisis, the CDC could distribute a SMART app to emergency departments as easily as a software developer submits an app to the Apple App Store?

JAMA Article (free)

RFP Language for Buying SMART-Compatible HIT


SMART Platform ( is a project that lays the groundwork for a more flexible approach to sourcing health information technology tools. Like Apple and Android’s app stores, SMART creates the means for developers to create and for health systems and providers to easily deploy third-party applications in tandem with their existing electronic health record, data warehouse, or health information exchange platforms.

To deploy SMART-enabled applications, health systems must ensure that their existing health information technology infrastructure supports the SMART on FHIR API. The SMART on FHIR starter set detailed below lists the minimum requirements for supporting the API and SMART-enabled applications. You may wish to augment this list of minimum requirements with suggestions from the Add-On Functionality listed depending on the types of applications your organization wishes to deploy.
Read more

C-CDAs — What are they good for?


David Kreda, SMART Translation Advisor
Joshua Mandel, SMART Lead Architect

Some readers of our JAMIA paper “Are Meaningful Use Stage 2 certified EHRs ready for Interoperability?” have wondered if we were insinuating that C-CDAs are all but useless because of their heterogeneity and other defects.

We did not say that.
Read more

Certification/MU tweaks to support patient subscriptions


This is a quick description of the minimum requirements to turn patient-mediated “transmit” into a usable system for feeding clinical data to a patient’s preferred endpoints. In my blog post last month, I described a small, incremental “trust tweak” asking ONC and CMS to converge on the Blue Button Patient Trust Bundle, so that any patient anywhere has the capability to send data to any app in the bundle.

This proposal builds on that initial tweak. I should be clear that the ideas here aren’t novel: they borrow very clearly from the Blue Button+ Direct implementation guide (which is not part of certification or MU — but aspects of it ought to be).

Read more

Health App Privacy Policies Still Wild Frontier


Apple may have just tightened privacy requirements for developers who build apps on its HealthKit platform. But a broad assessment of the industry, published online last week in JAMIA, found that the iTunes and Google Play stores have a long way to go before such policies are readily discoverable and digestible to app users.

Improving patient access: small steps and patch-ups


In a blog post earlier this month, I advocated for ONC and CMS to adopt a grand scheme to improve patient data access through the SMART on FHIR API. Here, I’ll advocate for a very small scheme that ignores some of the big issues, but aims to patch up one of the most broken aspects of today’s system.

The problem: patient-facing “transmit” is broken

Not to mince words: ONC’s certification program and CMS’s attestation program are out of sync on patient access. As a result, patient portals don’t offer reliable “transmit” capabilities.

2014-certified EHR systems must demonstrate support for portal-based Direct message transmission, but providers don’t need to make these capabilities available for patients in real life. Today, two loopholes prevent patient access:
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SMART Advice on JASON (and PCAST)


As architect for SMART Platforms and community lead for the Blue Button REST API, I’m defining open APIs for health data that spark innovation in patient care, consumer empowerment, clinical research. So I was very pleased last month at an invitation to join a newly-formed Federal Advisory Committee called the JASON Task Force, helping ONC respond to the JASON Report (“A Robust Health Data Infrastructure”).

We’re charged with making recommendations to ONC about how to proceed toward building practical, broad-reaching interoperability in Meaningful Use Stage 3 and beyond. Our committee is still meeting and forming recommendations throughout the summer and into the fall, but I wanted to share my initial thoughts on the scope of the problem; where we are today; and how we can make real progress as we move forward.

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It’s About Time: Open APIs Finally Burst onto Healthcare’s Sluggish Scene


Nuviun Blog, June 9, 2014 — Sue Montgomery
In the midst of the struggles that we face with interoperability, efforts that support open API use may well hold the keys to the HIT Kingdom…