Next week is the final opportunity for public comment on the ONC’s proposed Trusted Exchange Framework and Common Agreement. I’ve prepared a set of comments and recommendations that focus on the scope and mechanics of individual access, including technical standards, security requirements, identity proofing, authentication, and authorization.
Given the importance of health data exchange to the SMART Health IT community, I’m sharing the full letter and 15 recommendations here in PDF.
January 30, 2018
Ken Mandl (Twitter @mandl)
Despite spectacular advances in diagnostic imaging, non-invasive surgery, and gene editing, healthcare still faces a lackluster problem: many patients can only get health records from their doctor if the fax machine is working. Even when records are stored electronically, different chunks of every patient’s health information sit in the non-interoperable, inaccessible electronic record systems in different doctor’s offices.
Anyone who needs her medical files gets them either printed or faxed, or has to log on into separate portals for each doctor and hospital, and even then getting view-only access. View-only apps can’t access data to help patients share information with family and healthcare providers, make decisions, monitor disease, stay on course with medications, or just stay well.
On the positive side, this is changing, sort of. Using the iPhone Health app, patients will soon be able to download and view health records on their phones. On the one hand, don’t get too excited–it will initially only work for patients at a handful of institutions, Android users are still out in the cold, and the data available will be limited. And, some dismiss the impact of Apple’s move because of others’ failures to give patients control of their records.
However, Apple’s move is a decisive and consequential advance in patients’ struggle to get a copy of their own health data. Apple wisely chose to use open, non-proprietary approaches that will float all boats–even for Android users.
Every patient deserves a ‘bank account’ of her health data, under her control, with deposits made after every healthcare encounter. After my colleagues and I demonstrated an open, free version of a “bank account” to companies in 2006, Google and Microsoft launched similar personally controlled health records — GoogleHealth and Microsoft Healthvault. Walmart and other employers offered our version, Indivo, as an employee benefit. Unfortunately, even these industry giants couldn’t shake loose data from the proprietary computer systems in doctors’ offices, or make the case to patients that curating the data was worth the effort.
But 12 years later, Apple’s product enters healthcare under different circumstances. A lot more patient data is electronic after a $48 billion federal investment in promoting the adoption of information technology to providers. But those products, mostly older software and purchased at enormous expense, still don’t promote record sharing with doctors or patients.
Recognizing this unacceptable limitation and having received a generous grant comprising a tiny fraction of that federal investment, our team created SMART on FHIR. SMART is an interface to make doctors’ electronic health records work like iPhones do. Apps can be added or deleted easily. The major electronic health record brands have built this interface into their products.
Apple uses SMART to connect the Health app to hospitals and doctors offices. The good news for patients, doctors, and innovators is that Apple chose a standardized, open connection over a proprietary, closed one. This approach lets any other app, whether running on the web, iPhone, or Android, use that very same interface to connect.
So Apple will compete on value and customer satisfaction, rather than on an exclusive lock on the data. Does Apple’s approach help Americans trying to stay well or manage their conditions? Yes. But only with follow-through by Apple, health systems, technology companies, patient groups, policy makers, and government regulators. The emerging ecosystem’s nuances must be appreciated.
First of all, the floodgates for patient information are at least a crack open and will be very hard to close. As patients gain access to their data, they will recognize it is incomplete and feel frustrated it’s not available everywhere. But, patients in need will drive demand for data access in their role as health consumers.
Secondly, the government is effectively using law and regulations to compel an open interface. By selecting SMART on FHIR, Apple and its healthcare launch partners mark the importance of standardization. A uniform approach is critical for scale. Imagine if every electrical product required a differently shaped 120V outlet. Understanding this, Google, Quest Diagnostics, Eli Lily, Optum, and many other companies are using the same interface to plug into healthcare.
Thirdly, Apple’s first version of health records brings data onto the phone, but from there, like the portals many patients are already familiar with, the data are still “view-only.” In 2009, I had the chance to meet with Apple’s rockstar Bud Tribble and talk about how the iPhone could serve healthcare. We concluded that crucial data–like the medication list–had to be as easy for iOS developers to use in their apps as contacts and location are now. I would not be at all surprised if this is the next step in Apple’s journey–making the health records available to iPhone app developers. Here too is an opportunity to chose open interfaces, and to allow patients to export the data to another device.
Lastly, competition in healthcare IT is hot. Amazon, Google, Apple and Facebook all have healthcare divisions. Apple’s extraordinary hardware, including sensors in the phone and watch, will monitor patients at home. Google’s artificial intelligence will lead doctors and patients to diagnoses and decisions. Amazon is rumored to be eying pharmacy management. Facebook has sifted through posts to detect and possibly intervene when users may be suicidal.
There are so many opportunities to compete. Locking up a patient’s data should never be one of them.
Ken Mandl, MD, MPH directs the Boston Children’s Hospital Computational Health Informatics Program and is the Harvard Medical School Donald A.B. Lindberg Professor of Pediatrics and Biomedical Informatics.
SMART Platform (www.smarthealthit.org) 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.
This document is intended as a resource for providers and health systems as they draft Request for Proposals (RFPs) and negotiate with their HIT vendors for added functionality. It has multiple authors from across the SMART team and its advisors. Feedback is welcome.
The vendor must support the SMART on FHIR platform, a vendor agnostic API that allows third-party developers to build external apps and services that integrate with the vended product.
At a minimum, the vendor product should include the following components in order to support SMART on FHIR and SMART-enabled applications:
The provider organization may also want to consider the following additions to its RFP depending on the types of applications it wishes to develop and run in the future.
The IP of any app integrated through the SMART on FHIR API belongs to the author and not the vendor.
Should a vendor neglect to provide SMART on FHIR natively, the client has the right to provide a custom extension to the vendor’s API. The ownership of the IP for the custom extension is negotiable between the client and the vendor, but the ownership of the app using the custom extension belongs to its author.
FHIR is laying a framework for digital disruption to occur. A big part of FHIR’s popularity is that it’s vendor-neutral and free to use, which allows innovators to do things that couldn’t easily be done before. […] The SMART on FHIR app platform and app gallery are great examples. Think of SMART on FHIR like the app store on a smartphone. Some of the apps are designed for physicians to use, such as the Growth Chart app developed by Boston’s Children’s Hospital. The app plots a child’s height and weight against growth charts published by the World Health Organization and U.S. Centers for Disease Control and Prevention (CDC) so that physicians can track a child’s growth over time and communicate this to the child’s caregivers.
Other apps in the SMART on FHIR gallery are patient-facing, such as the ClinDat application, which makes it easier for rheumatoid arthritis patients to document which joints are normal, tender, or swollen. These data are captured electronically and sent back to the medical record in real-time to support the clinical care patients receive. The beauty of SMART on FHIR is the apps are vendor neutral and can be ‘plugged-in’ to EHRs and other tools used on multiple devices (particularly mobile devices) that are already integrated into clinicians’ workflows.
SMART Platform (www.smarthealthit.org) 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.
Continue reading “RFP Language for Buying SMART-Compatible HIT”
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.
Continue reading “C-CDAs — What are they good for?”
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).
Continue reading “Certification/MU tweaks to support patient subscriptions”
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.
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:
Continue reading “Improving patient access: small steps and patch-ups”
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.
Last week I reported on a set of security vulnerabilities that affected multiple EHR vendors and other Health IT systems.
I initially discovered the vulnerability in a single Web-based EHR system and successfully reported it directly to that vendor.
But my subsequent journey into the world of EHR vulnerability reporting left me deeply concerned that our EHR vendors do not have mature reporting systems in place. Patient health data are among the most personal, sensitive aspects of our online presence. They offer an increasingly high-value target for identity theft, blackmail, and ransom. It’s time for EHR vendors to take a page from the playbook of consumer tech companies by instituting the same kinds of security vulnerability reporting programs that are ubiquitous on the consumer Web.
I’ll lead with the key message here, and provide supporting evidence below: HL7 and EHR vendors need to institute security vulnerability reporting programs!
Continue reading “Disturbing state of EHR Security Vulnerability Reporting”