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News Briefs - Proposed Budget Cuts Could Greatly Impact Healthcare Sector - House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880...more
News Briefs - Joint Employer Rule Withdrawn by National Labor Relations Board - The National Labor Relations Board withdrew its appeal of a district court ruling that enjoined its "joint employer" final rule....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more
Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more
News Briefs - FTC Aims to Take Action on Non-Competes, M&A Enforcement - Healthcare lobbying organizations' efforts to carve out industry-specific exemptions in recently proposed Federal Trade Commission policies are...more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more
NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more
CB Insights summarized 2020 corporate venture capital (“CVC”) financing trends in 2020 in its recent report. Globally, CVC-led deals raised over $73.1 billion in 2020 in 3,359 transactions....more
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more
Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more
On September 22, 2020, the U.S. Food and Drug Administration (FDA) announced the establishment of the Digital Health Center of Excellence (DHCE) within FDA’s Center for Devices and Radiological Health (CDRH). Bakul Patel will...more
Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
Harnessing existing digital health solutions to improve chronic care management was a prominent topic at HIMMS this year (amongst many others, including AI and cybersecurity, both of which we will cover in upcoming blog...more
As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to...more
Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
PricewaterhouseCoopers (PwC) and CB Insight recently released the results of its US MoneyTreeTM Report on U.S. venture funding for the first quarter of 2017. The report indicates that venture capitalists invested $13.9...more