A signature feature of the last several months has been the scramble for masks, shields and gowns – personal protective equipment (PPE) – for doctors, nurses and other care workers. Governments have been focused on ensuring that health authorities,
Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations.
The Health Sector Payment Transparency Act is one
Telemedicine has been rapidly expanding in the United States. Indeed, Texas recently passed legislation that gives Texas telemedicine providers more flexibility, including the ability to establish a physician-patient relationship in connection with telemedicine services without requiring an in-person visit. Business
In March 2016, the Austrian Supreme Court granted an award for pain and suffering to a patient for mental strain after a piece of broken scissors was left in his body following a surgery despite the fact that the claimant had not suffered any physical pain.
Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People with Chronic and Complex Health Conditions report. Key elements of the proposed scheme included:
On May 4, 2016, the U.S. Food and Drug Administration (FDA) signed a “systems recognition arrangement” with the Canadian Food Inspection Agency (CFIA) and Health Canada recognizing the comparability of the U.S. and Canadian food safety systems. This is only the second time that the FDA has recognized a foreign food safety system as comparable, with the only other recognized system being New Zealand signed in 2012. However, similar systems recognition arrangements are underway between the FDA and Australia and the European Commission.
The use of technology in the health sector is on the rise. The intersection of these two industries leads to interesting legal questions relating to digital risk, including big data analytics, data security and privacy.
In his budget speech on
On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much. The Minister said the review sought to ensure that the PBAC Guidelines are “consistent and transparent, while incorporating international best practice and removing any unnecessary regulatory burden on the pharmaceutical industry”. The review is being carried out by Adelaide Health Technology Assessment (AHTA) in conjunction with PBAC.
From 1 July 2016, new country of origin labeling requirements will become a reality in Australia, with a new food labeling system commencing under the Australian Consumer Law. The implementation of the new system will have a two year
Our newly released guide shares the top ten things to know about tapping into China’s medical devices industry. The guide provides an overview of the regulatory regime for medical devices in China and the top issues that foreign investors and manufacturers should consider when entering the China market.