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to classify “medical device data systems” or “MDDS” as Class I devices. This rule was issued in final form three years later in 2011. MDDS are systems that electronically transfer and store medical data; electronically convert medical data from one form to another in accordance with preset specifications, and electronically display medical device data. Medical device data are any electronic data available directly from a medical device or that were obtained originally from a medical device. An MDDS, therefore, is a device through which medical device data are passively transferred or communicated, but does not interpret or alter such medical device data or create or generate any of its own data—except data related to its own functioning. For example, software that collects output from a ventilator about a patient’s CO2 level and transmits the information to a central patient data repository is an MDDS.
regulation of health IT.
FDA’s Recent Efforts to Balance Innovation and Safety in the Regulation of Health IT
The Director of FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, MD, JD, has described the Agency’s approach to regulation of health IT as “smart regulation.” Agency officials have described smart regulation as involving (1) a focus on higher patient risk technology and software (2) selective use of regulatory tools appropriate for the technology (3) a scaling back from the traditional risk classification scheme for devices (Class I, II, and III) and (4) relying on a quality systems approach. As examples of this approach, they have cited the MDDS rule, which does not require premarket submissions for this technology; and the draft FDA guidance issued in July 2011 on mobile medical applications. The draft guidance on mobile medical applications, which is expected to issue in final before Oct. 1, 2013, is intended to address only a small subset of mobile medical applications that meet the statutory definition of “device”: “(1) apps that will be used as an accessory to a regulated medical device; and (2) apps that transform a mobile platform into a regulated medical device.” Other apps that meet the definition of device that are not covered by the draft guidance will be subject to enforcement discretion. These may include patient selfmanagement apps and simple tracking or trending apps that are not intended to impact treatment. FDA has stated that it intends to monitor the performance of these other apps to assess whether further regulation is necessary to protect the public health.
Safety Issues Presented by Health IT
While MDDS present a relatively low risk, other software-based systems meeting the definition of “device” present potentially greater risk. For example, systems that are used to control infusion pumps present a risk of medication overdose, and the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size. Safety concerns also are presented by some software apps relied upon by physicians in making diagnostic and treatment decisions in acute, critical situations—possibly from a r