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- Additionally, the FDA has come out with draft guidance and has promised final guidance regarding mobile medical apps.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.
Uncertainty abounds regarding the potential regulation of smartphone apps by FDA and other international regulatory bodies. For this discussion we’ll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing – or going to do – about new and innovative products that meet the definition of a medical device.
What is a Medical Device?
Let’s start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many vendors (and providers) who are outside the ranks of traditional medical device manufacturers. The first issue we need to address is the question, “What is a medical device?” Here’s the legal definition of a medical device, courtesy of FDA:Read More
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.Read More
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.
A public meeting on Converged Communications and Healthcare Devices Impact on Regulation (see here) was convened by the FDA and FCC on July 26-27, 2010. The major topics addressed by panels were (1) Current State of Wireless Health & Lessons Learned, (2) Innovator Perspective, (3) Healthcare Provider, Clinician & Patient perspective, (4) Investor and Research & Development perspective, (5) Reliability – How to Define Quality of Service, and (6) Electromagnetic Compatibility – How to Promote EMC. A complete transcript of the meeting will be forthcoming at the conference link given above, or at www.regulations.gov using the docket number FDA-2010-N-0291. The docket folder currently includes about 35 written comments made in advance of the meeting including from concerned citizens, professionals and professional groups, and major medical device and communications companies.
The stated motivation for this meeting included concern for the proliferation of devices using radio technology as well as reliance on consumer grade communication devices. In part this reflects potentially overlapping regulatory areas with the FCC on the spectrum side and the FDA on the medical device side. In addition to the usual array of medical device performance issues, the radio arena presents the additional challenges of the shared spectrum space, and the suitability of general purpose devices and systems for medical applications.
The major questions addressed at the meeting included data integrity and reliability, medical device and system security issues, allocated and unlicensed spectrum utilization, joint regulatory requirements, and risk management. The latter included the need to define levels of device criticality (which may then correspond to device FDA classification), and potential performance issues in multiple environments.
The FDA and FCC issued an associated joint press release (here) in which they reiterated the generally held belief that innovations in medical device communication “holds significant promise for enhancing health and reducing cost.” They further reiterated that these applications require agencies to assure that such devices operate in a safe, reliable and secure manner, while also encouraging innovation and affording the public the potential benefit of such devices. In part this will benefit from clarity and predictability with respect to the regulations as the agencies fulfill their mandate to protect the public from unsound devices and/or unsound device performance. In this regard it is certainly a challenge to the FDA to both tighten regulations (e.g. with respect to infusion pumps, and likely with respect to the 510(k) process), while also trying to be pro innovation.
Two issues that will have to be resolved here, and for some wired applications as well, are distinguishing real medical devices from health related toys, and where an integrated and regulated medical device ends and a less regulated general purpose communications or computer network begins. The commercial health toy arena has a strong element of regulatory avoidance, which might be acceptable with clear and honest marketing, and some way to exclude date from such devices from being confused with actual medical device data. It should also be clear that a medical device performing a critical function cannot operate at the whims of smart phone and internet performance when we have ample demonstration that these systems are not in fact reliable. Being unable to make a simple phone call, blog or text is one thing while being unable to send important information to a healthcare provider, who is in turn relying on being able to receive such information, is quite another.Read More