Informatics

Article – FCC, FDA, ONC seek input on mHealth regs

dondennison Healthcare IT , , , , , , ,

I find the topic of this article interesting.

Here’s why…

  • We have had notebooks and netbooks on WiFi accessing Web-based and other types of applications deemed medical devices (e.g. PACS) for years. The essential difference between a tablet and a netbook is the keyboard. They pose the same risk as a client application platform.
  • If this is what regulators are worried about, wait til they get a load of the bigger billy goat coming across the bridge next …mobile apps are one thing, but what about a portal framework that aggregates patient data from distributed sources, in real-time? Imagine a screen where each discrete element of the patient record is managed in a different system. The values used to define and indicate normal and abnormal test results are from a public Web site. Where does the “medical device” start and end? Who is the “manufacturer” responsible if an issue arises? How do you manage the medical device labeling? With mobile, we are simply trying to figure out how to do what, in many cases, we do today, only now without a wire. …regulatory affairs folks are in for a world of change (or healthcare will fall ever farther behind the IT curve).

Quebec EHR …the difference 2 years makes

dondennison Healthcare IT , , , , , , ,

The news from today (May 2013) “Quebec to expand $1.6 billion EHR“. And, from 24 months ago (May 2011), “Quebec’s EHR late and over budget, AG says“.

One thing is for sure: implementing an EHR of that size and scale (with public funds), is not for the faint of heart.

Healthcare reform inspires innovators

dondennison Healthcare IT , ,

A friend forwarded this article on to me. It is great to see the energy being put into innovation in healthcare IT—it certainly needs it.

I have attended a few talks on the challenges facing start-ups when entering the realm of healthcare applications. Not only is healthcare a complex domain, with established vendors too often hoarding data in closed systems, but the whole issue of potentially having to becoming a registered medical device manufacturer can be daunting. I am hoping that some entrepreneurs with experience in regulatory affairs and quality system management emerge to provide affordable consulting services to start-ups. Full-time regulatory staff are often expensive and bureaucratic.

I have a written a couple of papers on innovation in different sized companies and environments. They will be published in the next few months. Stay tuned.

Article – Readers Write: 256 Shades of Grey(scale): The Dirty Little Secrets of Radiology and PACS

dondennison Healthcare IT , , , , , ,

Contrary to what the title suggests, this article debates whether radiology has succeeded in solving the problem of going digital (by using PACS).

I believe that PACS solved the initial problem that it was intended to solve: get rid of film. Whether it provided more value than that had a lot to do with the design of the PACS, and who was managing it.

But, the value of PACS has a lot more to do with how it is deployed, configured and managed. If a PACS owner fails to use informatics and operational best practices, they and their users will suffer. If they fail to invest in and manage the infrastructure—such as the networks, servers, and storage—they will suffer.

I have seen too many PACS operators with too heavy of a dependence on their PACS vendor. Radiology and IT too often lack staff that understand informatics, integration best practices (e.g. as defined by IHE), or how their system operates. I have seen two hospitals with the same software application doing very similar exam volumes, and one experienced high levels of user satisfaction and operational excellence, while the other had chronic issues.

I would argue that in today’s mature PACS market, it is not what you buy, but how you use it. Provider staff need skills and knowledge about best practices. They need to know more about PACS in general, and be less constrained to knowing only what their PACS vendor tells them. And one of the best places to develop these skills and broad knowledge is SIIM.

I’ll be at the SIIM meeting—stop and say ‘hi’ if you see me.

Apps for Health – Tips for Building an App, Key Trends in Health IT

dondennison Product Management , , , , , ,

Prezi presention from @azbib (Heart and Stroke foundation) from today’s Apps for Health event.

Product developers, have a read: 10 great, practical tips on approaching app development that applies to mobile and traditional application products.

Also, some key trends in health for 2013 (originally from Forbes).

Apps for Health 2013 at Mohawk College

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Mohawk1

I had heard good things about this one-day conference, so I decided to take the drive down to Hamilton, ON to check it out. I am glad I did.

Apps for Health has 3 tracks. One focused on Technology, one on Health, and another on Education. They also had keynote speakers to open and close the day of sessions.

To be honest, I was fearing that the recurring trend was going to go something like this: “Healthcare is broken! I love the App Store! Why can’t we get more apps faster!?!” …but the speakers were polished and came with insight and data.

Topics ranged from the needs for a “prescription” for a set of apps for different patient conditions, different levels of safety and risk that apps represent (for physicians and patients), regulatory challenges, privacy, security, and development approaches.

A collection of small and not-so-small vendors had table top displays set up, and attendees (and students) seemed to be routinely interacting with the vendor staff.

Having never been to Mohawk college before, I have to admit that I was quite impressed with the facilities. The buildings are very modern. Everywhere you look, you see technology—on the walls, in the classrooms, in the library, in the hands of the students …everywhere.

One of the more enjoyable parts of my excursion to The Hammer (nickname for Hamilton), was a tour of the Mohawk MEDIC lab. The students demonstrated a complete workflow of a patient’s journey through a referral from her family doctor, to an exam with a specialist (an allergist), and an unfortunate skiing accident in a remote area.

They showed how an EMR—in this case, the open source OSCAR EMR—could accept the referral and share it with the specialist by using an IHE XDS infrastructure. They then showed how the specialist could perform the exam and share the results back to the EMR using the same methods. They also showed the use of mobile technology by EMT and ER staff to review the patient’s records before administering treatment, thus avoiding a potential adverse incident (the allergist report found her allergic to penicillin and other drugs).

Mohawk is serving its students well. They are not only learning about the real world challenges facing healthcare, they are learning about how to build and apply open solutions, and use the latest tools to do it. And they are doing it in a fantastic facility. If you know someone thinking of going there, at least go for the tour—you won’t regret it.

Article – DoD yanked from health records project

dondennison Healthcare IT , , , , , , ,

This article is intriguing (and a bit depressing).

First, because it shows once again that the amount of money (say like, US$1 billion) that you throw at a problem does not assure success. Aligning goals and system design principles—and getting firm commitment from all stakeholders—is critical, and it doesn’t seem like that happened here.

Also, there is no mention of the use of commercial HIE technology for record exchange. The article mentions the exploration of commercial EMR technology vs. a custom (“home grown”) EMR, like the VA’s VistA. How is the ONC—a government agency—promoting the use of HIE solutions as part of their patient record evolution, but the VA and DoD not looking at the same approach?

Finally, the vision of an open system is not flawed. And by open, I mean interoperable with modern Web-based APIs. It could even mean open source.

Article – AMA: EHRs create ‘appalling Catch-22’

dondennison Policy , , , , , ,

I enjoyed this article.

Often, policymakers and executives debate the merits of an initiative. What is often lost in the shuffle are the important lessons and optimizations that make the program a success.

In the article, a number of folks discuss the implications of an EMR after implementation, including the possibility of fraud, or the incorrect perception that it has occurred.

My thoughts…

  • Fraud is easier to detect the more the information is electronic and coded. In fact, any pattern is easier to detect if extensive, well-structured data is available. Algorithms that detect possible fraud patterns will emerge, just as they did for credit card transactions. I recall a investigative news show on Medicare fraud where the agent stated that the move to electronic transactions and ‘smarter and smarter’ alogrithms have made their job easier. False positives will be a problem for a while until they get it right.
  • Coding of records is about to become a huge push. Beyond regulations for coding of data, there are several initiatives to provide codes for orderable procedures, lab/clinical observations, medical terms, diseases, medical/surgical/diagnostic services, and even imaging workflow concepts. Other groups are working to provide practical guidance on how to best use these codes in different contexts. This article talks about the need for better and more coding.

And here is an article on a Web site where EMR users can rate their EMR. There are some interesting comments in the article.

Also, an Accenture survey finds a significant increase in the use of EMR and HIE technology by physicians.

Article – Can a smartphone do what your doctor does?

dondennison Healthcare IT , , , , ,

This article provides a summary of medical devices and apps that connect to your smartphone and collect physical examination information. The author is a doctor and provides a good explanation of the utility and necessity of the different tests.

The devices assessed by the article’s author include…

  • Blood Pressure Monitor by Withings and Blood Oxygen Monitor by iSp02
  • ECG Cellphone Case by AliveCor
  • iExaminer by Welch Allyn
  • SpiroSmart

From her assessment, it seems that the medical tricorder is slowly becoming a reality. I do agree that having a separate app to view the results from each device is a PITA, but this should not last long. With Bluetooth and WiFi connected devices wireless tethered to the smartphone, and new data formats and protocols popularized in HTML5, the shift to storing the collected information into the EMR or HIE will be soon.

Blog – FHIR Version 1.0

dondennison Healthcare IT , , , , , ,

Check out this blog discussing FHIR. While the initial post seeks to simplify the intent of FHIR to a practical application (essentially a summary document), if you read the author’s own comments on their post, they are already starting to realize the real value of FHIR.

FHIR creates the platform, and the summary document is an application of the platform.