Amcom Software Acquired by USA Mobility
Amcom Software was acquired March 3, 2011, for $163.3 million in cash (press release). USA Mobility, one of the few companies left standing in the declining pager industry, purchased the company to strengthen their position in health care, and move beyond paging into messaging and unified communications.
Amcom was built through a series of acquisitions, including messaging middleware vendor CommTech Wireless. The CommTech Wireless solution provides event notification, including alarm notification that is called out in the final MDDS rule by FDA for enforcement discretion. Amcom’s plans regarding potential FDA regulation or limiting marketing claims (to exclude alarm notification) are not known. The company was undecided when asked about it at HIMSS in 2010. One would hope that this issue arose during USA Mobility’s due diligence.
UPDATE (3/7/11): Ron Wenaas for Amcom Software writes, “as one of the leaders in this space, Amcom Software is absolutely pursuing compliance with the recently published FDA regulations.”
Final MDDS Rule Signals FDA Shift to Enforcement
On February 14, 2011 the FDA published notice (PDF version [link fixed] and press release) of the long awaited final rule for medical device data systems (MDDS). The real news behind the final MDDS rule is not the less-burdensome path to market trumpeted by many news stories, but the FDA’s stated intent to exercise “enforcement discretion” with regard to those who create MDDS. For the MDDS vendors who are already regulated (Capsule Tech, Cardiopulmonary Corp, Dawning Technologies, Nuvon and others) this final rule is an easing of the regulatory burden. For those that aren’t (e.g., Bridge-Tech Medical, CareTrends, iSirona and others – I currently track 16 companies in the MDDS category) this final rule signals that FDA enforcement actions will be forthcoming for manufacturers that don’t meet FDA’s implementation deadlines (more on that later).
The final rule reclassifies MDDS from a Class III postamendment device to Class I (general controls). Device reclassification has been used before to signal industry that FDA is transitioning from “regulatory discretion,” where the FDA takes a wait-and-see approach to nascent markets, to pursuing “enforcement discretion” to actively regulate new market segments.
Announcing the 2011 Medical Device Connectivity Conference
This year’s connectivity conference is scheduled for September 8-9 at the Joseph B. Martin Conference Center at Harvard Medical School in Boston. This is the same location as the inaugural conference in 2009, and was a great venue for both general sessions and break-out tracks. Exhibitor’s booths line the wide walk ways that lead to the conference rooms, rather than a separate lobby (or tent as we had in San Diego in 2010).
I’m already working to line up speakers – if you’ve got a topic to suggest, or want to present yourself, let me know.
The focus of this year’s conference may extend a bit beyond the acute care (hospital) market into ambulatory settings (patient’s homes and use in daily life). Now there are already several conferences on connectivity in ambulatory markets (Healthcare Unbound, mHealth Summit, Connected Health Symposium), but they focus little on specific connectivity issues.
Conference topics typically come from recent and current issues that crop up in my consulting practice, and buzz in the industry (which is where you come in). Here are some of the topics that are being considered for this year’s conference:
mHealth Summit, Washington DC
This week I’m at the mHealth Summit, an event bringing together research (academic), technology (business), and policy (NGOs and government). On Tuesday (November 9) I’ll be on the panel, Validation and Practical Deployment of Wireless Health, at 11:30 (Room 102 A & B). I’ll be touching on the differences between verification and validation testing, and the challenges of simulated validation testing. The panel will be discussing what constitutes sufficient objective evidence for validation testing and different approaches to validation from both a technical, clinical and business perspectives.
The event is just kicking off as I’m writing this (loud techno music before the speakers come up to the podium). Focus is squarely on wireless broadband (cell phones) offering ubiquitous connectivity. Applications discussed provide education, diagnostics, therapy delivery and monitoring.
The Twitter hash for this conference is #mhs10. The opening keynote is being held in a full ballroom at the Washington DC Convention Center. There are an estimated couple thousand attendees– I’ll provide an official number later.
Impact of Potential FDA Regulation of EMRs
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.
