A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of electronic medical device equipment manuals. Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of [...]
On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In The American Economy, the order sets forth, in overview, measures designed for federal agencies to coordinate actions to address the problems of unfair competition, overconcentration, and economic consolidation. The executive order acknowledges the harmful anticompetitive effects of monopolies [...]
The House of Representatives voted overwhelmingly Tuesday to kill a sales tax on medical devices that the medical-technology industry around the country have battled for nearly a decade. Industry insiders hope that Tuesday’s vote will provide the momentum that leads to action by the end of the year. Read more here.
Medical device recalls reached record highs in the first three months of 2018 thanks to software complications that are likely to continue with the proliferation of high-tech devices. Read more here.
For the second consecutive year, healthcare was the sector hardest hit by cyberattacks, according to Cylance's 2017 Threat Report released May 1. In its report, Cylance — a cybersecurity firm that uses artificial intelligence to protect against threats — reviewed attacks that affected its global customer base, which spans multiple industry sectors, in 2017. Read [...]
On June 7, 2017, the U.S. House of Representatives Energy and Commerce Committee approved an amendment to the FDA Reauthorization Act of 2017 which will require the FDA to submit to the House and Senate Committees a report on how the FDA intends to ensure the quality and continued effectiveness of devices with respect to [...]
Independent servicers across the nation have registered with their congressional representatives strong disapproval to the proposed independent servicers legislation. Read more here.
The FDA Medical Device User Fee Amendments (MDUFA IV) package is heading to a Senate committee vote — and it appears not to include any of the House legislative language on independent servicer registration. Read more here.
Provided below is the link to the hearing held before the House Energy and Commerce Subcommittee on Health on 5/2/2017. The testimony of our general counsel Robert Kerwin and the questions placed by U.S. Congressional members to IAMERS and to MITA are important to our members. To see more about the hearing. Click here.