About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

S. 1101, Medical Electronic Data Technology Enhancement for Consumers' Health Act 1 (July 11, 2016)

handle is hein.congrec/cbo3065 and id is 1 raw text is: CONGRESSIONAL BUDGET OFFICE COST ESTIMATE July 11, 2016 S. 1101 Medical Electronic Data Technology Enhancement for Consumers' Health Act As reported by the Senate Committee on Health, Education, Labor, and Pensions on April 4, 2016 SUMMARY S. 1101 would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to exempt certain medical software from regulation as a medical device and, as a result, from an excise tax on such devices. Because enacting the bill would affect revenues, pay-as-you-go procedures apply. However, CBO and the Joint Committee on Taxation (JCT) estimate that those losses would be less than $500,000 over the 2017-2026 period. Enacting the legislation would not affect direct spending. S. 1101 also would direct the Secretary of Health and Human Services (HHS) to classify and regulate accessories to medical devices separately from the device they operate. In addition, the legislation would require preparation of a report on the risks and benefits of using medical software. CBO estimates that implementing the legislation would cost the Food and Drug Administration (FDA) $60 million over the 2017-2021 period, assuming appropriation of the necessary amounts. CBO estimates that enacting S. 1101 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027. S. 1101 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA). ESTIMATED COST TO THE FEDERAL GOVERNMENT The estimated budgetary effect of S. 1101 is shown in the following table. The costs of this legislation fall within budget function 550 (health).

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most