On May 24th, the Congressional Budget Office (CBO) released its score of H.R. 1628, the American Health Care Act of 2017 (AHCA), as passed by the U.S. House of Representatives. The CBO estimates that the AHCA would reduce
European Union’s new medical device regulations come into force
Today, 25 May 2017, two new Regulations come into force in the European Union: the Medical Device Regulation (MDR) which replaces two EU Directives on general medical devices and active implantable medical devices; and the In Vitro Diagnostic Medical
Formula milk suppliers targeted by Singapore competition authority
On 10 May, the Competition Commission of Singapore (CCS) published a market study report on formula milk supply to babies, infants and young children in Singapore. The CCS commenced its review of the formula milk market in October 2015 due
Centers for Medicare & Medicaid Services issues health care reform directives; Senate committee passes telehealth bill
While the Senate continues to work on its version of health care reform legislation, the American Health Care Act of 2017 (AHCA), the Centers for Medicare and Medicaid Services (CMS) has been busy streamlining and de-regulating current processes under the
Bipartisan effort to provide greater transparency into federally-negotiated settlement agreements
This week, U.S. Senators Elizabeth Warren (D-MA) and James Lankford (R-OK) reintroduced a bill designed to provide the public with more information about settlement agreements between federal agencies and companies and individuals. The bill, called the Truth in Settlements Act
FDA and NIH finalize clinical trial protocol template
On May 2, 2017, the U.S. Food and Drug Administration (“FDA”) and The National Institutes of Health (“NIH”), through the NIH-FDA Joint Leadership Council, released the final version of a clinical trial protocol template in an effort to assist investigators
Recent European developments in mHealth regulation
Mandatory kilojoule labeling – Victoria, Australia
The Victorian Government has introduced the requirement that all major Victorian food outlets and supermarket chains must display kilojoule contents on their menus.
The Food (Kilojoule Labelling Scheme and Other Matters) Amendment Act 2016 will, from May 2018, require large
U.S. Senate begins considering health care legislation; CBO to release score of American Health Care Act next week
Congressional work on health care legislation took a back seat last week to President Trump’s firing of FBI Director James Comey. Nonetheless, there was some health care activity.
As previously reported, on May 4 the U.S. House of Representatives passed
Texas Legislature moves to expand permissible telemedicine services in Texas
On May 11, 2017 the Texas House passed Senate Bill 1107 (“SB 1107”), which greatly expands the telemedicine services physicians can provide in Texas. SB 1107 passed the House with the support of substantially the entire House. Senate Bill 1107