Thursday, February 13, 2014

S 2007 Introduced – Medical Software

As I mentioned earlier this week Sen. Fisher (R,NE) Introduced S 2007, the Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014, a bill to limit the regulation of various types of medical software. Its intent is similar to HR 3303, but the provisions are subtly different.


Section 3(a) of the bill would add two new definitions to 21 USC 321; ‘clinical software’ and ‘health software’. Clinical software is intended to be used in a clinical setting by trained medical personnel. It would capture, analyze, change or present clinical data and perhaps even recommend treatment, but does not actually act upon or change the body. Health software is not clinical software though it may similarly may capture, analyze, change or present patient clinical data or to provide administrative or operational support to health care, or act as a platform to run or connect other software; but is not used in direct patient care.

Exempts from Coverage

Section 3(b) would add a new section to Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 351 et seq.) that would prohibit clinical software and health software from being regulated under the FFFDCA.

Section 4 of the bill would exclude clinical software and health software from the definition of ‘device’ under 21 USC §321(h).

HR 3303 specifically gave FDA authority to regulate medical software other than clinical software or health software. This bill does not do that; it essentially ignores all other medical software once it blocks coverage of clinical or health software.

One of the consequences of this bill would be that it would leave no agency of the federal government to regulate the security of any medical software other than that which specifically controls the operation of medical devices. The authority to regulate that software is derivative of the authority to regulate devices, not specifically spelled out in the USC.

Moving Forward

This is a rather obscure bill and somewhat technical in nature. It is unlikely that this will capture the attention of enough members to command action. If it catches the attention of someone in the right position, it might be able to make it through floor action under one of the limited debate processes used to advance non-controversial legislation. It is more likely to advance by being added to an authorization bill or a spending bill; again that would require special support for the legislation from someone in a key leadership position.

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