More on Clinical Decison Support and EMRs
I have previously discussed Meaningful Use (MU) criteria for EHRs (here and here) , and Clinical Decision Support (CDS) (here). These topics are closely linked since the MU requirements mandate the inclusion of CDS.
On February 22, 2012 the Centers for Medicare and Medicaid Services (CMS) released (in a mere 455 pages in manuscript form) a proposed rule for Stage 2 criteria for qualification of an EHR for the Medicare incentive program. Among many topics, the proposed rule includes some elaboration on the mandatory use of CDS’s as well as issues related to their design and utilization.
2012 – Year for mHealth?
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- Additionally, the FDA has come out with draft guidance and has promised final guidance regarding mobile medical apps.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.
Lessons from a Recent Recall
A recent Class I recall (not pictured) of a medical monitor with a hospital network connected central station stimulates some generalities about software, “fixes”, and connectivity. (Class I recalls are defined by the FDA as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.)
The use of the product in question was given as:
- a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs
Curiously only one customer was identified as having received the product, or at least this particular version of the product. While the manufacturer and product in question is a matter of public record, and available at the link, I chose not to include it here because my objective is not to repeat the recall information, but to suggest the reasons for the recall, an associated labeling issue, and offer some general lessons.
The IOM on EHRs
The issue of the EHR relative to safety and effectiveness has again made the news with the November 7, 2011 pre-publication (and downloadable) release of an Institute of Medicine report on EHR safety, commissioned by the U.S. Department of Health and Human Services (HHS). This report expands the discussion beyond the EHR (used henceforth for both EHR and EMR) to include other related electronic information tools collectively called health IT.
Health IT Risks
The potential for health IT to improve both the quality and efficiency of medical care has been much noted to include more complete and timely records, ready exchange of information between providers, clinical decision support, and in turn a reduction in errors associated with the quality and availability of patient information. Efficiencies may arise from electronic capture of data which would eliminate manual entry, and time savings in accessing and reviewing patient information, and perhaps in passing information to third party payers. Additional public health value might accrue from the enhanced searchability of electronic records with respects to trends, treatments and outcomes. These benefits assume well designed, user friendly, compatible systems not withstanding that the U.S. model is to allow for numerous independent products that may or may not be able to exchange information nor display it in a consistent manner. Not surprisingly the report notes that the IT imperative will likely not be fruitful without associated attention to the people and the clinical system they work in.
Wi-Fi Capacity and New Devices
A recent NY Times article reported that hotel Wi-Fi capacity was again being challenged, this time by iPads and other tablets, or more specifically, tablet users. The Times notes that these users may have a smart phone and laptop going at the same time they are sucking up streaming video. The high bandwidth demand of these devices, or more specifically, their uses, is said to be reducing download speeds back to the good old days of dial-up connections. A likely solution will be a tiered charge structure, similar to the newest cellular data plans, with the result that you can waste bandwidth if you don’t care what it costs. A more general report on current and future wireless demand versus capacity has been produced by the Global Information Industry Center at the University of California San Diego. A less foreboding report on medical uses of Wi-Fi has been produced by the Wi-Fi alliance.
Smart phones have a prior history of overwhelming cell phone networks, such that in dense environments someone can’t make a phone call because too many other people are watching reality show reruns and bad movies. Now some cellular devices have been looking at switching to Wi-Fi when it is available, as explained here. This leads to the conflict ridden situation of cellular wanting to use Wi-Fi to solve its capacity problems at the same time that Wi-Fi is being over loaded by other devices. Cellular resistant building structures, which are increasing, also can create a desire to shift to Wi-Fi.
Call for Contributing Authors
Today I was contacted by a social media marketing firm working for a major MDDS vendor with an offer to contribute content that’s on topic for this site (that last part is important). I’m interested, and I imagine a lot of this blog’s readers will be too. As I will likely take them up on their offer, I want everyone to understand that there’s not any favoritism that plays into who gets to post on this site. So, the following describes the ground rules, the benefits of contributing, and issues an open invitation to contribute posts.
We’ve been fortunate to have a number of terrific contributing authors over the years, and some of them have written posts that continue to be popular to this day. On the About This Site page is a long standing open invitation to anyone who wants to climb up on the soap box and spout off contribute to the conversation about medical device connectivity. I’ve also made contributing author offers personally to many folks on both the provider and vendor sides of the table. There are so many people who have incredible knowledge and experience to share. And most of these people don’t have the time or inclination to create their own blog. Now you have an outlet.
Hacked Insulin Pump
The fact that connectivity, and perhaps wireless connectivity in particular, allows for hacking for mischief, theft, politics, social protest and other forms and varying degrees of evil should surely come as no surprise. In turn, that a wireless medical device might be hackable should be somewhere on the mind of developers, users, and regulators. Thus the report from the recent Black Hat conference that someone hacked an insulin infusion pump, and in so doing was then able to alter its settings, should also not be particularly shocking, but should serve as yet another reminder, that security associated with connectivity has been and continues to be an issue, as was addressed by Tim back in 2006.
The report in this instance came from Jay Radcliffe who hacked his own insulin delivery equipment. In this instance the hacking avenue was the wireless remote that was part of the device. Perhaps the idea that a wireless remote could be emulated is even at the ultra low end of surprise. More generally, the multiple discussions of this report (e.g. here and here) have suggested that the technology being used by at least some medical device manufacturers does not offer an adequate array of security safeguards. Or the manufacturers haven’t fully utilized what is available in terms of alternate hardware, or they havn’t fully utilized the security features that were available even in the hardware that they were using.
Third Medical Device Connectivity Conference
This September 8-9, in Boston, will be the third Medical Device Connectivity conference. We’re returning to the Joseph B Martin Conference Center at Harvard Medical School – a really nice facility with great food. Of course, the ambiance and cuisine is secondary to what you’ll learn at this year’s conference – still the only event dedicated to medical device connectivity.
Since last year’s conference so much has come to pass:
- The FDA published their final rule for Medical Device Data Systems, and signaled their intent to regulate health care providers who develop their own MDDS solutions.
- The FDA also published the long anticipated draft guidance on mobile apps, clarifying the boundaries around what is and is not regulated medical device software, and laying out a bit of the FDA’s enforcement strategy.
- The transition of health care technology from the hospital to home health has also received some attention from the National Research Council in their report, Health Care Comes Home: The Human Factors.
Mobile Apps Guidance Q&A
On LinkeIn this morning, I came across a couple of comments about the FDA’s recent draft guidance on mobile apps. Thoughtful comments by David Doherty and Nathan Billing in a LinkedIn discussion prompted the following. My imperfect interpretation of their comments was the impetus for this post.
David suggests that FDA regulation will stifle mobile app innovation, and observes that brand-name phone manufacturers are in a better position to shoulder FDA regulations than startups. He further wonders why an App Store that takes a 30% cut of app revenue does not appear to draw any regulatory attention from FDA.
Nathan agrees that over-regulation could stifle innovation and suggests that the regulatory burden should vary based on the intended user. Nathan implies, I think, that apps for health care professionals should face greater regulatory scrutiny than apps for use by patients. He also laments that FDA has not designated specific standards that would facilitate cross-vendor interoperability in the mHealth ecosystem.
FDA Addresses Mobile Medical Apps
As medical applications for mobile devices have proliferated, regulatory questions have proliferated nearly as fast, at least in some quarters. The key questions are what kinds of apps are medical devices, and among those, which will the FDA focus on for regulatory action. To date these apps range from home use adviser’s, guides and “toys”, which may or may not have real health care implications, to serious medical devices which have clear health care functions, despite in at least some cases, pretending they do not really, perhaps in an attempt to avoid the FDA.
On July 19, 2011 the FDA announced its proposed official action in this regard, including defining “mobile medical applications” that are the subject of this action. (I will use the acronym MMA, although the FDA did not.) . This includes a new FDA web page for mobile apps (here), with links to a new Draft Guidance, information for consumers, and a press release. This action by the FDA has a parallel to the recent final rule on Medical Device Data Systems (MDDS), discussed by Tim here, which also addressed what is it, what is it not, and how that which is will be regulated.
