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.
FDA/FCC on Wireless Medical Devices
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.
Progress (?) on Clinical Decision Support
The AHRQ has released a report (available here) on the implementation of clinical decision support (CDS) software within the context of an EMR. This report reviews the work to date of two AHRQ demonstration grant recipients, Brigham and Women’s Hospital and Yale University School of Medicine. In each of these projects the intent was, at least in part, to implement two or more existing practice guidelines as on line and integrated component of the EMR.
In the context of these projects CDS means the provision of clinical knowledge and patient-specific information to help make decisions that enhance patient care. While this type of general statement remains somewhat vague as to what constitutes such help, the report comments further that in a CDS “the patient’s information is matched to a clinical knowledge base, and patient-specific assessments or recommendations are then communicated effectively at appropriate times during patient care”. Therefore, as used here, CDS is more than just the effective presentation of integrated patient information, as might be done by a Medical Device Data System (as discussed here) for example. Instead it is knowledge based and the relevant knowledge is used to compare a patient to a predefined pattern in order to “suggest” or “advise” (or “tell”) the clinician what course of treatment is to be followed.
In this regard a CDS is, in older and somewhat forgotten terminology, an expert system. Introduced in the late 1990′s,the idea of an expert system was that the knowledge and expertise of one or more human experts could be captured and implemented as a computer code. Once this code was written (and perhaps verified), it would be possible to enter a new situation within the domain of the expert system, and the expert system would then provide the same result as the original expert or experts. It was further believed that some expert systems could be written that could “learn” such that it actually became more expert than the original experts whose knowledge was tapped (by a knowledge engineer) in its original creation. Of course such learning could only occur if the expert system was given controlled feedback along with having a coding scheme that was self adjusting. Neural nets was one of the popular approaches to such learning.
The 25 Elements of “Meaningful Use”
The Recovery Act that initiated the process of providing incentive payments for the adoption and use of Electronic Health Records (EHR) included the provision that such systems support “meaningful use” if they are to be certified and funded. Of course if you have to have meaningful use, then meaningful use has to be defined, and them measured. After a round or two of proposals and comments, CMS issued an Interim Final Rule on December 30, 2009. (The idea that a Final Rule can be Interim is itself a masterwork of government speak.) The governments discussion of this process is available here. The Interim Final Rule itself (which runs over 30 pages) is entitled “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Interim Final Rule” and it is available here. A companion rule posted in the Federal Register (FR) on January 13, 2010, “Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule” is available here. All of this is part of the Health Information Technology project in the Department of Health and Human Services which is lead by Dr. David Blumenthal who is the National Coordinator for Health IT.
These rules defines 25 functions that together constitute meaningful use. Each of these also has a level of performance that is required for ultimate certification (as listed in the January 13th FR). For example, the first use (see below) of “Use Computer Provider Order Entry (CPOE)” has the criteria that it is used for at least 80% of all orders; but only 10% for hospitals. How an EHR is actually used by the provider is an interesting and important distinction from what the system is capable of, i.e. if the system provides for CPOE but if the users don’t use that capability to an adequate degree, then by these definitions meaningful use is not achieved. Thus what the EHR can do is a necessary but sufficient condition to establish its certifiablity.
The 25 elements and an abbreviated statement of the associated measures are:
1. Use Computer Provider Order Entry (CPOE) (80%/10% hospitals)
2. Implement drug/allergy checks (Enabled)
3. Maintain an up-to-date problem list of current and active diagnoses (80%)
4. E-prescribing (Eligible Professional (EP) only) (75%)
