Legislation

How Can Healthtech Innovations Transform Indonesia's Healthcare System?
Digital Health How Can Healthtech Innovations Transform Indonesia's Healthcare System?

In the wake of the COVID-19 pandemic, Indonesia's healthcare system has revealed significant gaps that demand immediate attention and innovation. One of the cornerstones of this transformation is the newly introduced Omnibus Health Law (Law No. 17 of 2023), which seeks to overhaul the sector

October 1, 2024
New Guide Simplifies Healthtech Law for Developers and Investors
Regulatory & Compliance New Guide Simplifies Healthtech Law for Developers and Investors

In the rapidly evolving sector of healthcare technology, a new book authored by Susan Lee Walberg aims to demystify the complex legal landscape for developers, investors, start-ups, and clinicians. Titled "Healthcare Technology: Law and Compliance, The User-Friendly Guide to Healthtech

September 26, 2024
California AI Transparency Act to Impact High-Traffic Health Websites
Regulatory & Compliance California AI Transparency Act to Impact High-Traffic Health Websites

Emerging legislation in California, known as the California AI Transparency Act, could bring significant changes to healthcare companies and other businesses operating high-traffic websites. Designed to enhance transparency and accountability, this bill focuses on content generated by artificial

September 24, 2024
Boston Scientific Acquires Silk Road Medical for $1.28 Billion
Regulatory & Compliance Boston Scientific Acquires Silk Road Medical for $1.28 Billion

The healthcare industry witnessed a significant move today as Boston Scientific announced the completion of its acquisition of Silk Road Medical. This transaction, valued at $1.28 billion, represents a strategic milestone for Boston Scientific, aiming to enhance their technological prowess in the

September 18, 2024
Will the BIOSECURE Act Hinder Innovation in U.S. Biotechnology?
Regulatory & Compliance Will the BIOSECURE Act Hinder Innovation in U.S. Biotechnology?

Amid rising concerns over national security and economic self-reliance, the U.S. Congress has introduced the BIOSECURE Act. Aimed at curbing Chinese influence in the biotechnology sector, this legislation prevents companies with Chinese ties from accessing federal funding. While the Act promises

September 12, 2024
Labs Urge Lawmakers to Rescind FDA Rule on Lab-Developed Tests
Regulatory & Compliance Labs Urge Lawmakers to Rescind FDA Rule on Lab-Developed Tests

The call for legislative intervention to overturn the FDA's final rule on the regulation of laboratory-developed tests (LDTs) has intensified. The Association for Diagnostics and Laboratory Medicine (ADLM) has been at the forefront, urging lawmakers to take action against the FDA's new

September 11, 2024
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