Epic’s overhauled sepsis model, Verily’s close FDA ties, & AI for biopsies

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Epic overhauls sepsis model amid scrutiny 

The Wisconsin health record giant is revamping its flagship sepsis prediction model following Casey’s investigations revealing high rates of false alarms and failure to reliably predict sepsis, according to documents obtained by STAT. In a major policy shift, Epic is now recommending that hospital customers train the model on their own data before deploying it, and has adjusted its definition of “sepsis onset” to align with a more commonly accepted standard.


The changes could make the model more useful to clinicians seeking to avert sepsis, Patrick Lyons, an intensivist and expert in risk prediction models at Washington University School of Medicine, told Casey. “That is likely to increase accuracy at a lot of different places, even those with vastly different case mixes.” Read the full story. 

Inside the Verily-FDA nexus 


The Alphabet life sciences spinout made a huge bet on evidence generation with its eye-popping $1 billion funding round, positioning itself to build tools for pharma and digital health customers running clinical trials. And its roster of high profile former FDA officials might be the key to ensuring its success — especially as regulators grapple with how to handle data gathered outside traditional clinical trials, Katie writes in a new analysis.

Two-time FDA Commissioner Robert Califf previously led health policy and strategy for Verily and Google, and has said collaborating with industry is a “major priority.” Amy Abernethy joined Verily in July 2021 after serving as FDA’s principal deputy commissioner and acting chief information officer; it’s since brought policy director Joe Franklin and senior technical advisor Laura Roe on from the agency, among others.

“FDA is certainly trying to broaden their understanding,”of real-world data and evidence, said Rachele Hendricks-Sturrup, research director of real-world evidence at the Duke-Margolis Center for Health Policy. “Everyone’s trying to grapple with the opportunities and challenges around determining whether or not real-world data is fit for regulatory use.” Here’s the full story.

AI to avert unnecessary biopsies 

In her first story for STAT, our intern Jayne Williamson-Lee dug into an AI tool that analyzes MRI scans for breast cancer risk to reduce unnecessary biopsies. Often, radiologists “don’t have enough certainty to make a very well-informed decision [about biopsies].So they err on the side of, let’s just biopsy a lot of people,” said Jan Witowski, who co-authored a paper on the tool in Science Translational Medicine.

In general, averting unnecessary biopsies could have major implications for patients, and “reduce patient anxiety, subject patients to less unnecessary exams and [procedures], and decrease associated health care costs,” said Manisha Bahl, a breast imaging radiologist at Massachusetts General HospitalRead more here.

On tap this week: information sharing compliance

A more expansive definition for “electronic health information” takes effect Thursday under federal rules, meaning that health systems and IT developers will be responsible for making more data available for patients to access and exchange, the federal government’s health IT office reminds us this week. 

Digital health deals’ lowest point since end of 2019 

Backers are holding off on investments til the market stabilizes, Rock Health finds in its quarterly digital health analysis. 2022’s third quarter saw just about $2.2 billion raised across 125 deals, only slightly more than the $2.1 billion raised at the end of 2019. In general, analysts found smaller deal sizes and more focus on early-stage funding compared to previous quarters.

Industry news 

  • Kaiser Permanente is offering Ginger’s emotional support coaching to its members starting today.
  • Northwell’s investment arm is making a $3 million bet on Hume AI, which uses machine learning to understand nonverbal behavior.
  • French-American startup Owkin, which uses AI to identify new medical treatments, has hired Sanofi’s global head of partnering Alban de La Sablière as its new chief business officer.
  • CVS Health sold bswift, a benefits software provider, to Francisco Partners. In January, the firm also bought the assets of IBM’s Watson Health business.

What we’re reading

  • It’s not clear how well mental health chatbots work, Wired 
  • How to navigate health apps that may share your data, ACLU
  • Zocdoc’s founder on the No. 1 health-care consumer problem that never changes, CNBC
Source: STAT