In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill on the “Law for better provision through digitalization and innovation”, which is expected to be approved by the parliament early November.
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For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could lead to new opportunities for market access of their products.
China: 2018 was another eventful year for the pharmaceutical industry, highlighted by the Chinese government’s radical attempts to slash drug prices by the annual national drug price negotiation and along with the introduction of a national procurement program.
Assobiomedica, the body representing the medical device sector in Italy, published an update to the report ‘Public Policies for the Purchase of Medical Devices’ in October 2018. Boston healthcare outline procurement trend in the Italian reimbursement environment.
A recent proposal by Jens Spahn, Federal Minister for Health in Germany, would limit the decision-making power of the Joint Federal Committee (G-BA) and lead to new evidence approaches for healthcare decision making.
Earlier this month, the Food and Drug Administration announced a new draft guidance for companion diagnostics. The guidance describes considerations for the development and labeling of companion diagnostics to support the indicated uses of multiple therapeutic oncology products.
Boston Healthcare spoke at the MedTech Access Leaders Forum in Berlin, Germany on 3-5 December 2018. Vice President, Rob Wenthold spoke on maximizing the organizational impact of the market access function, and CEO, Joe Ferrara spoke on global considerations for companion diagnostics. Register your details to receive your copy!
Earlier this month we hosted a forum on Health Information Technology with a Delegation from the China Development Research Foundation (CDRF)
On June 25, 2018, the Chinese Ministry of Justice announced amendments to the Supervision and Administration of Medical Devices Regulations (the Regulation) and called for public comment. The proposal is being celebrated by a variety of stakeholders across the medical device and IVD industry following years of lobbying to have the Regulation amended. However, some apprehension regarding the implementation of the proposed Regulation remains. Download the PDF