article thumbnail

Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

The selections feature topics ranging from a review of modifications to blood glucose monitoring systems and related patent protections, an examination of insulin price changes from 2012-2019, and a discussion of why a proposed federal bill that would ban government health care programs from using the quality-adjusted life-year is misguided.

Medicaid 130
article thumbnail

Microsoft life sciences leader on what makes for successful disruptors

Healthcare It News

As the digital transformation in healthcare lags behind other industries and value-based care drives provider efficiencies while the government invests in healthcare cost reduction and access measures, health tech is positively overripe for disruption.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years. The sectorialism of the U.S.

FDA 289
article thumbnail

Public Health Product Hops

Bill of Health

Regulatory and patent exclusivity periods govern the timing of generic entry, and because market share and revenue is often quickly lost upon market entry of generic drugs, extending market exclusivity for any duration can be extremely profitable. As such, product hopping is generally viewed as problematic.

article thumbnail

Health Care Software Double-Bills Government For Anesthesia Services According to FCA Suit

The Health Law Firm

Board Certified by The Florida Bar in Health Law On November 2, 2017, a relator in a Florida federal False Claims Act (FCA) case, claimed that Epic Systems' (Epic) health software wrongly defaults to double-billing for anesthesia services. Indest III, J.D.,

article thumbnail

Climate Change and Neglected Tropical Diseases: Key Takeaways from the WHO-WIPO-WTO Trilateral Symposium

Bill of Health

Speakers at the Symposium included the Directors General of all three organizations as well as representative government officials, non-governmental organizations (such as Médecins Sans Frontières/Doctors Without Borders and the Drugs for Neglected Diseases Initiative), and industry participants (Novartis).

article thumbnail

Modernizing Medicine To Pay $45 Million To Settle False Claims, Kickback Allegations

Healthcare IT Today

EHR vendor Modernizing Medicine has agreed to pay $45 million to the federal government to settle a whistleblower suit alleging that the vendor engaged in varied kickback schemes as well as causing its provider customers to submit false claims. The lawsuit was filed in 2017 by law firms Phillips and Cohen LLP and Downs Rachlin Martin PLLC.