On July 29, 2022, the Calendar Year (CY) 2023 Medicare Physician Fee Schedule (PFS) proposed rule was published in the Federal Register. The proposed…
Artificial intelligence and healthcare are hardly strangers, as machine learning programs have been aiding in the diagnosis of disease, drug…
Digital therapeutics (DTx) have emerged as an interesting addition to conventional pharmacological solutions, offering innovative ways to improve…
With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow…
The Fiscal Responsibility Act, the product of intense negotiations between the White House and House Republican leadership, suspends the debt limit…
This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth…
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the…
For digital health startups, the first two months of this year were a welcome departure from 2022, when high inflation and other economic challenges…
On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health…
For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was…
Investing is cyclical. It’s a lesson that has repeated itself over the past two years for entrepreneurs and investors in emerging digital health…
