This post was also written by Robert J. Hill and Jennifer A. Goldstein. In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). In this analysis, … Continue Reading
The Federal Communications Commission (FCC) just announced that, as part of its implementation of the recently released National Broadband Plan and the Plan's recommendation to use the power of broadband to improve healthcare, the FCC and the Food and Drug Administration (FDA) are going to be holding a public meeting on July 26 and 27, 2010, to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices. The meeting is formally entitled: "Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes." The purpose of this meeting is, among other things, to discuss ways to promote investment and innovation in health technology by streamlining government processes.
To help develop an agenda for this important meeting, the FDA and the FCC are seeking input from, among others, the medical and device manufacturing industries, practitioners, and other stakeholders and users of medical technology on a number of questions regarding regulatory challenges and safety of patients and other users of medical devices that include radio elements and of systems that can be tied into broadband communications networks.… Continue Reading
In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms.… Continue Reading
On May 28, 2010, just shy of the June 1st compliance deadline, the Federal Trade Commission announced that it would again be postponing enforcement of the Red Flags Identity Theft Prevention Rule through December 31, 2010. This delay comes at the request of Congress, which has been considering legislation (which has been referred to the Senate Committee on Banking, Housing, and Urban Affairs) that would affect the scope of entities covered by the Rule. The FTC "urges Congress to act quickly to pass legislation that will resolve any questions as to which entities are covered by the Rule and obviate the need for further enforcement delays." If Congress passes legislation limiting the scope of the Red Flags Rule with an effective date earlier than December 31, 2010, the Commission will begin enforcement as of that effective date.… Continue Reading
