I received several items in my email regarding different organizations’ proclamations for 2012. Most of them predict that 2012 will be the year for mHealth to ‘break-out.’ Here are 5 examples:
- HIMSS 2012 is focusing on mHealth with several sessions and will have a kiosk on the vendor floor which features speakers on the mobile aspect of healthcare
- AAMI has published in their IT World column a synopsis of mHealth (requires login credentials)
- Here in Europe, the Mobile World Congress, Barcelona Feb 2012, sponsored by the GSM Association, has a track devoted to mHealth (filter for Mobile Health), a day of demonstrations and a specific plan on embedded mobile medical functionality.
- Additionally, the FDA has come out with draft guidance and has promised final guidance regarding mobile medical apps. The European Commission has entered into an MOU with the HHS to work together on the regulatory aspects of healthcare. I wouldn’t be surprised if they come out with similar regulatory guidance regarding mHealth as that promulgated by the FDA.
Santa Rosa Consulting has a great series of webinars on medical device connectivity and related issues, and I’ve been tapped for the October webinar. My topic revolves around the likely regulation of EMRs by the FDA and the potential impacts such a change might have on providers and manufacturers.
The following is my first take on the topic, and serves as a description of webinar. Any suggestions, points of view and links to relevant content on the Web (news stories, blog posts, regulations, etc.) is welcome.
Register for this webinar here, to be held on October 27, 2010 from noon to 1pm EST.
The Case for Regulating EMRs
From a quarter century point of view, it seems inevitable that the HIT industry will be regulated by the FDA. Look past all the hand waving and hyperventilating caused by this suggestion, and one sees that the HIT industry is already regulated by the FDA. For examples, look no further than blood bank software and PACS. The Center for Biologics Evaluation and Research (CBER) started regulating blood bank software via the premarket submission process in 1996. From their inception, the FDA considered PACS as accessories to diagnostic imaging modalities, and thus regulated. (Many PACS components have since been reclassified in recognition of their independence from imaging modalities.)
These examples aside, the HIT industry has pretty much avoided FDA scrutiny by claiming they’re just automating administrative tasks and paperwork (i.e., workflow around the paper chart).With the advent of decision support systems tied to CPOE and other applications, “administrative” HIT systems have come to be increasingly recognized as a source of patient safety risk. See Margalit Gur-Arie’s post at the KevinMD blog.Perhaps the story that’s created the most buzz about the danger of EMRs is this Huffington Post piece from April, 2010.
On February 25, 2010, at a HHS panel meeting, Jeff Shuren reported:
The Food & Drug Administration has received 260 reports of health IT-related malfunctions with the potential for patient harm in the past two years, including 44 reported injuries and six reported deaths, said Dr. Jeffrey Shuren, director of FDA’s Center of Devices and Radiological Health.
Connectologists rejoyced this month (September, 2008) when Healthcare Informatics magazine published Biomed Joins the Party – Savvy CIOs are considering biomedical devices in their overall strategic plans (link). To my knowledge, this is the very first cover story in a major health care IT magazine about medical device connectivity. As an aside, diagnostic imaging pubs have been writing about connectivity in their market for many years.
Contributing editor, Mark Hagland, casts the drama that is connectivity as “two worlds colliding,” – the worlds of IT and biomedical engineering. He builds his story around the integration of medical devices to support EMR charting. In fact, medical device connectivity started almost 20 years ago with the integration of Apple IIs and IBM PCs (not to mention a few funky HP mini computers) in diagnostic areas like the cath lab and in the ICU. Probably the biggest wave of connectivity to date has been PACS (picture archiving and communications systems) and the adoption of DICOM. Now the health care industry is zeroing in on connectivity at the point of care with patient monitors, smart infusion pumps, point of care testing, and yes, EMR integration (by far the most expensive point of care application).
Using Trinity Health as his template, Hagland describes an ideal approach to medical device connectivity: the involvement of IT, clinicians, and biomedical engineering. The 40 odd hospitals in Trinity’s system have over 110,000 medical devices. Trinity has used this approach to more effectively manage these colliding worlds:
The biomed integration initiative actually began several years ago in an effort to cut costs, Fierens [the hospital exec over Biomed] reports. But as Project Genesis [their EMR project] has moved ahead, and as the technology in the biomed equipment area has advanced, the broader goals of improved care quality and workflow have come more fully into focus, he says. The biggest challenge, says Fierens, is that “you’ve got to balance the economics with the infrastructure and support, along with the service element, along with the clinical outcome you’re trying to support.”
The route to medical device connectivity for hospitals is neither clear or straightforward.Read More
I’ve been wrapping up a pretty big project and so posting has been light this week. I do have some things that caught my eye this week that I will post later this weekend. Earlier this week I was asked:
- what connectivity capabilies are being built into medical devices now,
- what factors are driving these changes, and
- what barriers in your area(s), what are they?
The biggest trends driving what I call medical connectivity are EMR integration, workflow automation and alarm notification.
The basic capabilities required to meet the above include:
- the ability to establish patient context, acquire and transmit data from the medical device
- a server to capture, store, queue and transmit data (optionally, an HL7 interface for EMR integration, and logic to analyze data)
- client applications (usually served up by the server) to enter, review and edit patient data.