for example, electronic medical textbooks, health IT involves the generation, manipulation, storage, and display of patient- and provider-specific data. This need for specificity imposes special requirements on information technology. When a provider reads a laboratory result from the computer screen or enters an order for a medicine by mouse or keyboard, the patient context matters a great deal.

Until now, health IT’s quality, accuracy, precision, reliability, and safety have been left almost entirely to vendors. Although facilities and, to a lesser extent, users can configure and adapt health IT for their own uses, as a practical matter it is the vendors who control what health IT looks like and how it performs. While this may be reasonable for consumer or even some commercial software and hardware, it is unacceptable for health IT that must provide high-level performance in a hazardous environment. Medical practice is inherently hazardous and devices used to care for patients are regulated.

Is health IT a medical device? If so, in the United States, FDA is charged with its regulation. According to law, a medical device is

… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. (Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 SEC. 201)

Health IT components include items such as computerized provider order entry (CPOE), electronic medical records (EMRs), or EHRs. These components participate directly in diagnosis, cure, mitigation, treatment, and prevention of specified individual human beings. Health IT is a medical device and FDA is or should be its regulatory body.

The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act established three regulatory classes for medical devices. Class I devices are the simplest and are least likely to cause direct or indirect harm. The tongue depressor is a Class I device (its entry is in the Code of Federal Regulations at 21 CFR 880.6230). Class II devices include devices



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