HSCC Legacy Medical Device Task Group Aims to Mitigate Cyber Threats

May 13, 2020 By Robert J. Kerwin This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/51199  In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 [...]

By |2020-05-14T16:45:54+00:00May 14th, 2020|Government, Healthcare|Comments Off on HSCC Legacy Medical Device Task Group Aims to Mitigate Cyber Threats

IAMERS CONTINUES TO ADVOCATE AS THE FDA SERVICING DEBATE RAGES ON DESPITE THE FDA REPORT RECOMMENDING NO NEW REGULATIONS

With rumors of a possible renewed push for Congressional legislation, IAMERS president Diana Upton and general counsel Robert Kerwin attended the AAMI Annual Meeting during the first week of June 2018. Their attendance is  part of IAMERS’ efforts to reduce the fear-mongering and  to get out the message of independent servicers for safe patient oriented [...]

By |2018-06-08T12:21:42+00:00June 8th, 2018|Government, Healthcare|Comments Off on IAMERS CONTINUES TO ADVOCATE AS THE FDA SERVICING DEBATE RAGES ON DESPITE THE FDA REPORT RECOMMENDING NO NEW REGULATIONS

Congress delays medical device tax for two years

WASHINGTON — Almost no one got everything they wanted out of the Monday deal to reopen the government — except perhaps medical device companies, who managed to fend off an industry-wide excise tax before the first payments were due.   The stopgap spending deal that was signed by President Trump on Monday included a two-year delay of the 2.3 percent [...]

By |2018-01-25T10:18:12+00:00January 25th, 2018|Business, Government|Comments Off on Congress delays medical device tax for two years

Nationwide hosts IAMERS forum on QMS in advance of FDA report

Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill. See the full story at DOTmed by clicking here.  

By |2017-08-18T11:06:19+00:00August 18th, 2017|Government, Healthcare|Comments Off on Nationwide hosts IAMERS forum on QMS in advance of FDA report

The Joint Commission Introduces New Element of Performance — Service Manuals

George Mills, Director of Engineering for the accrediting organization, The Joint Commission, announced yesterday at the American College of Clinical Engineers (ACCE) meeting a new element of performance expected which essentially requires healthcare organizations to have on hand  service manuals and technical bulletins: EP 3 provides "The organization has a library of information regarding inspection, [...]

By |2017-06-10T13:25:06+00:00June 10th, 2017|Business, Government|Comments Off on The Joint Commission Introduces New Element of Performance — Service Manuals

Servicing Legislation Update

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 [...]

By |2017-06-08T13:51:21+00:00June 8th, 2017|Government, Regulatory|Comments Off on Servicing Legislation Update

MITA Continues To Omit In Its Proposed Servicing Standard

MITA continues to omit in its proposed Servicing Standard device manufacturer responsibility to provide appropriate documentation for technical descriptions, instructions for use and preventive and corrective maintenance and repair procedures, despite ANSI/AAMI EQ56: 2013. IAMERS after receiving a copy of the latest version of MITA's servicing standard, notified MITA that the Standard continues to impose [...]

By |2017-06-06T19:52:53+00:00June 6th, 2017|Business, Government, Healthcare|Comments Off on MITA Continues To Omit In Its Proposed Servicing Standard
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