Abstract
On February 4, 2011, the U.S. Food and Drug Administration (FDA) announced approval of the software, Mobile MIM, as appropriate for interpretation of computed tomography, magnetic resonance imaging, and positron emission tomography on iPhone and iPad when a full workstation is not available. The standards for interpretation of radiographic images have been very carefully studied with regard to patient images and transmitted images by the American College of Radiology and the sanctity of adequate images has been very important to the telemedicine community as distant interpretation moved forward in the last 10 years to include offshore interpretation and remuneration. The FDA regulators reviewed MIM results with a variety of portable devices for image quality, etc., and participating radiologists were in agreement that the device permitted processing of images adequate for diagnostic interpretation. This is the first FDA approval of a mobile imaging application and surely not to be the last in the coming months and years.
Now that there are some 1,500 medical applications that are available for mobile telephony and 200 million licenses in the United States expected to triple this year, it is very timely that federal regulators represent the public interest in the approval and regulation of such applications to avoid problems of poor service or indeed to lose the faith of the practicing community and consumer public. The use of software for mobile devices in diagnostics and disease management is sure to increase and to remain central to the use of telemedicine in the coming model of patient-centered care. The review horizon could include monitors for blood pressure, glucose, and other physiological parameters where data are acquired in the mobile stetting, transmitted for interpretation in telemedicine, and stored in an electronic record. Such a review process would apply to all software that might be appended to the electronic medical record. The Centers for Medicare and Medicaid Services (CMS) issued its 864 pages of meaningful use detail for electronic health records in the summer of 2010 and the Office of the National Coordinator has issued a companion set of rules on certification for electronic records that runs to 228 pages. This would seem sufficient. However, the extensive documents are silent on the matters of tracking and reporting of errors in electronic records. There have been such errors and they undoubtedly will continue as the uses of electronic data collection, storage, and management proliferate.
On July 26, 2010, the FDA and the Federal Communications Commission (FCC) held public meetings to determine the extent of regulation for wireless devices. Why is the FCC concerned? They are concerned at the level of FDA Commissioner Hamburg and FCC Commissioner Genachowski to make broadband worthwhile and to assure the benefits to medical care and cost reduction. They are concerned because the transmission of medical information is a hugely important part of the federal broadband initiative administered by the FCC. It is clear that wireless and smart devices have a huge potential for efficient and distributive health management but the need for regulation was early recognized. The potential for enhanced care and reduced costs should not be subject to anything less than exquisite oversight to support appropriate public confidence. In September 2010, the FDA announced the development of draft guidelines and to clarify policy on the regulation of mobile devices. Public comment was invited. The pace of regulatory evolution from summer to February is usually only seen in case of national emergency. The span of only a few months from intent to public comment to the first approval is extraordinary, laudable, and highly indicative of the perceived importance of the regulation of software and electronic medical devices. Dr. David Blumenthal, head of the Office of the National Coordinator, asked the Institute of Medicine to convene a panel to study “all options assuring safety.” The contract for nearly a million dollars was initiated in December 2010 and recommendations are anticipated.
Mobile medicine facilitated by monitoring devices, software for data synthesis, and transmission for interpretation are very much a part of the emerging medical scene and the coming model for the practice of medicine. The public seems ready and now the regulators are active to protect the public interest. Where are medicine and the telemedicine community?
It is a custom in medicine and industry to be highly suspicious of layer after layer of regulation. There could be a great consternation in this instance, as yet another medical advance in data management and interpretation enters the vast and branching halls of federal regulation. However, in this instance, there is cause for celebration and congratulations. The rush to regulation seems to be practical and very quick. In contrast to the ghastly backlog of years in the patent process, we have a medical revolution finding regulatory peace in only months. It must be clear that this glory time of congratulations cannot last! There will be mistakes, conflicts among agencies, endless quarrels about remuneration, and bitter fights among competitors in development of the devices and among the user community. The high ground is available for the telemedicine community. Think of the patients. What can we do with our expertise, creditability, experience, and profound concern for patient safety and access? Of course we should be actively engaged in the deployment and evolution of the guidelines. We must be prepared for what could be called the long haul! Whenever a matter arises in your specialty area, research area, commercial domain, or administrative role, be willing to provide your best-balanced and data-driven advice to keep up this pact of technology transfer to active patient care without compromises to safety or the integrity of the practice community. Forward!