Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.

Healthcare Brew

Quinn Sental

Healthcare Brew delivers the latest news and trends in healthcare.

healthcare-brew.com

An image of a red cross, pill bottles, and health carts surrounding a phone. 

Digital tools may ease inequities in maternal healthcare, report finds

It’ll all boil down to equity-centered design, according to the Deloitte Center for Health Solutions.

Ransomware 101: The need-to-knows for healthcare execs

The Change Healthcare cyberattack may be just the beginning.

Amanda Eisenberg

HCA Healthcare pilots Google AI to aid handoff documentation

The large language model processes a 12-hour shift and condenses the highlights into a report that helps the next nurse pick up where the previous left off.

A computer processor icon denoting healthcare technology

Tech

Maia Anderson

The Department of Health and Human Services (HHS) is cracking down on actors that prevent access to patient health data.

The agency said in a Sept. 3 press release it’s implementing new policies to enforce information blocking rules, which were established under the 21st Century Cures Act in 2016, including potential fines of up to $1 million per violation. Information blocking can cause delays in patient care, increased healthcare costs, and physician burnout, according to the American Medical Association (AMA).

“Once a tolerated industry practice, information blocking is now a target for real accountability. And that means better, faster, safer care for patients,” Bobby Mukkamala, president of the AMA, said in a Sept. 10 statement.

Any practice that potentially interferes with or prevents the access, use, or exchange of electronic health information—except in cases required by law—is considered information blocking. That data includes anything in a patient’s medical chart, like pathology reports and imaging results, according to Josh Newman, VP of clinical systems at Johns Hopkins University.

Three parties are regulated by the HHS rules: healthcare providers, health information exchanges (networks that facilitate the exchange of health information between different entities), and developers of certified health IT (typically makers of electronic health record, or EHR, tech like 

EHR vendors would have the most incentive to block information, as they may do so for competitive purposes, Newman said, adding that healthcare providers more often violate information blocking rules due to factors like a lack of resources or misunderstanding of the rules. 

Epic, for example, is one of the largest EHR vendors in the US and has roughly 42% of the acute care EHR market share, according to KLAS data cited by 

Epic is currently facing two lawsuits—one from health data platform 

—accusing the company of impeding access to patient data for anticompetitive purposes.

 in 2024 when Particle’s lawsuit was filed that the claims were “baseless” and the company’s software is “open and interoperable.” In response to the CureIS lawsuit, an Epic spokesperson told CNBC in May the company “look[s] forward to setting the record straight in court.”

Information blocking has been an issue in the healthcare industry for years, according to the AMA, and can have consequences such as delayed patient care and physician burnout.

For instance, if a patient were to have testing done at one health system and then seek continued care at another, but the two systems didn’t exchange that person’s health information, the second system may repeat tests, Newman said. That could waste time and money.

Though information blocking penalties have been 

 for more than a year, HHS has not taken any enforcement actions to date, according to Newman.

It’s not clear why HHS is focusing on enforcement now, but it could be partly attributed to the new administration taking over and increasing 

According to the HHS press release, healthcare providers found to be violating information blocking rules could be “subject to disincentives” under the Medicare and Medicaid programs. Health IT developers could face financial penalties of up to $1 million per violation. And developers with products certified by HHS’s Office of the National Coordinator could have their certifications terminated.

The agency “will deploy all available authorities to investigate and hold violators accountable,” Juliet Hodgkins, HHS’s acting inspector general, said in a statement. “We are committed to enforcing the law and protecting patients’ access to health information.”

A computer screen displaying the text 'ACCESSING...' with animated rectangles transitioning from green to red with a block icon and a 'FAILED' message appearing.

HHS says it’s upping enforcement of information blocking rules

And violators could face up to $1 million in fines. 

Nicole Ortiz

Occasionally, we schedule our rounds with Healthcare Brew readers. Want to be featured in an upcoming edition?

Dani Bowie, SVP of workforce AI at travel nursing agency Aya Healthcare, began her career as a nurse and has moved into “helping hospitals run more efficiently.” With Aya specifically, she’s in a role where she taps into how AI and predictive analytics can ensure nurses are scheduled “in ways that support their well-being and help hospitals manage labor costs,” she said.

We spoke with Bowie about how her work has evolved and how the tech she works with factors in.

This interview has been edited for length and clarity.

What’s the best change you’ve made or seen at a place you’ve worked?

 remains one of the most complex challenges for hospitals and health systems. Where efficiency and automation are lacking, and resources are misaligned, that’s where technology can make the largest impact: by transforming scheduling. What previously took hospital nurse leaders hours and days can now take less than five minutes with the right technology.

What’s the biggest misconception people might have about your job?

, there are a lot of misconceptions about AI in healthcare. AI isn’t intended to replace clinicians but rather enhance their work and help them practice to the top of their licensure. The tools we’re developing are built to save nurse managers hours per week of manual effort—that kind of time savings is invaluable.

What’s the most fulfilling aspect of your job?

As a former health system executive, seeing the technology I designed and created implemented in hospitals across the country is so rewarding. It’s ensuring nurses like me are caring for patients at the bedside rather than being 

, staring at a computer screen covered in sticky notes, buried deep in spreadsheets until they’re cross-eyed.

What healthcare trend are you most optimistic about?

I’m really optimistic about how technology will 

 streamline processes, better utilize their resources, and improve alignment between previously siloed units. Technology is helping frontline leaders get away from mundane and tedious work so they can focus on what’s most important: patient care.

How this healthcare exec is helping make health systems more efficient with AI

Dani Bowie oversees how Aya Healthcare implements the tech, with hopes of reducing burnout.

The healthcare industry has seen an increasing number of 

 in recent years, and time is running out for Congress to renew legislation that experts say is key to detecting threats before an attack takes place.

Deemed the Cybersecurity Information Sharing Act of 2015, or CISA, the legislation makes it possible for organizations that scan for cyber threats to share information about potential bad actors before a cyberattack occurs and without potential legal liability. But the act is set to expire on Sept. 30, and experts told Healthcare Brew that without it, the healthcare system would be more vulnerable. 

“When information is not shared, it gives an upper hand to the attackers because they go undetected,” Mike Nelson, VP of digital trust at cybersecurity firm DigiCert, said. “The unfortunate result is that, as less information is shared, attacks will certainly go up.”

Before the legislation was passed, if an organization detected a threat for a potential cyberattack, it might have been hesitant to share that information for fear of legal liability, according to George Pappas, CEO of healthcare cybersecurity compliance company Intraprise Health.

“You’re really asking parties to share [information] before they have a solution,” he said.

What CISA did was remove that liability component so organizations were protected when sharing information about potential bad actors.

“Information sharing around cybersecurity is a critical aspect of protection,” Nelson said. “For example, if one hospital gets hit from ransomware, they can rapidly share how they were attacked, the details of that attack, and it can arm the rest of the industry to say, ‘Hey, we can now prevent that.’”

If CISA is allowed to lapse at the end of September, hospitals and healthcare organizations at large will likely see more successful cyberattacks “because organizations would be less prepared to respond to those attacks,” Jon Moore, chief risk officer and SVP of consulting services at healthcare cybersecurity company Clearwater Security, said.

Cyberattacks are already a huge problem in healthcare. The industry had the most cyber threats last year among all critical infrastructure industries, according to the FBI’s 2024 Internet Crime Report, which listed a total of 444 ransomware and data breach incidents in healthcare. The same year, the Change Healthcare cyberattack 

Without CISA, organizations will likely return to sharing less information on potential cyber threats because their legal teams will advise caution without the protections the act offers, Nelson said.

Two senators—Mike Rounds, a Republican from South Dakota, and Gary Peters, a Democrat from Michigan—introduced a bill in April to extend CISA by another 10 years. 

In a press release announcing the bill, Rounds said allowing CISA to lapse could “significantly weaken” cybersecurity ecosystems, “removing vital liability protections and hampering defensive operations across both the defense industrial base and critical infrastructure sectors.”

No progress has been made on advancing the bill, but 

 reported on Aug. 19 the House Homeland Security Committee confirmed plans to mark up the bill when Congress comes back from its August recess.

Since CISA was passed, the healthcare industry has seen “tremendous improvement” in keeping organizations protected from cyber threats, Nelson said, adding, “I just hope that progress continues.”

Red folders in the shape of a hospital cross with a mouse pointer

How hospitals may be affected if 10-year-old CISA cybersecurity law is allowed to lapse

Congress has until the end of September to renew the law, which allows organizations to share information about potential cyber threats.

How hospitals may be affected if a 10-year-old cybersecurity law is allowed to lapse

illustrated headshot of caroline catherman, healthcare brew reporter

Caroline Catherman

The number of FDA-cleared artificial intelligence-enabled medical devices has 

 in 2023 to 1,247 as of Aug. 28, according to the federal agency’s 

And healthcare systems are getting on board. In a 

, about 88% of 233 health system executives said their system uses AI.

Though only a small percentage have been recalled, 60 AI-enabled devices racked up 182 recorded recall events as of November 2024, according to an Aug. 22 JAMA 

Throughout these recalls, there was a consistent thread: Publicly traded companies’ devices (about 92%) were recalled more frequently than private companies’ devices (53%).

“That was really something we were surprised by because we were thinking public companies probably have better risk management,” Tinglong Dai, Bernard T. Ferrari professor at the Johns Hopkins University Carey Business School and one of the paper’s authors, told Healthcare Brew.

The paper theorizes public companies could feel pressure from investors to put out devices as quickly as possible, perhaps not giving them time for more thorough research.

“Investors, they want to see year after year you have new AI devices cleared by the FDA, you have AI devices being rolled out among healthcare providers, so the pressure itself might have contributed to the recalls,” Dai said. 

There were several main reasons for the recalls—a designation that ranges from a quick software update to total market removal—with 109 recalled due to diagnostic or measurement errors, 44 for a functionality delay, 14 for physical hazards, and 13 for biochemical hazards.

“If you have a misdiagnosis, obviously the entire healthcare delivery could be subject to risk because wrong diagnosis means that you could also have the wrong treatment,” Dai said.

The research letter identified another pattern, too. The majority (40% from the private companies, 78% from established public companies, and 97% from smaller public companies) of the recalled devices weren’t clinically validated before they were approved.

 are given the greenlight through the FDA’s 510(k) pathway, which clears a device if it proves it is “substantially equivalent” to a previously cleared device. Clinical data is not normally required to get an OK via a 510(k), as opposed to other clearance processes.

This is something health systems and providers should keep in mind when deciding 

“From the user’s perspective, I think it’s extremely important to understand…the difference between reported performance and real-world performance,” he said.

Even AI programs with strong premarket clinical data “frequently” perform worse in diverse real-world clinical settings, according to a March 2025 

This is one of the reasons the American Medical Association uses the term “augmented intelligence” rather than “artificial intelligence,” according to the organization’s website. AMA 

 says that AI is not supposed to call the shots or operate without oversight by a human healthcare professional.

A Department of Health and Human Services spokesperson told Healthcare Brew the agency “is not able to confirm” the numbers cited in the JAMA study, but “remains committed to ensuring patients have access to safe and effective medical devices, including those enabled with AI.”

In addition to general device software validation and safety requirements, the agency released 

 in January specifically for AI-enabled devices, like what data and documentation is needed to show safety and effectiveness.

Tinglong Dai’s title has been clarified.

Pill capsule with tech system inside, slightly open, and a honeycomb-like web in the background

Over 90% of recalled AI-enabled medical devices were from public companies

Though only a few AI-enabled devices have been recalled, patterns are emerging.

Cassie McGrath

 (EHR), you likely think of Epic, as the healthcare software company has records for 325 million patients and is the largest in the US.

And when you think of the modernization of the EHR, you may think of AI scribes like 

, the note-taking assistants designed to speed up clinical documentation.

Scribes can save physicians 15,000+ hours in work per year, 

 published in the journal NEJM Catalyst Innovations in Care Delivery reported, and between $200 billion to $360 billion in annual healthcare spending, 

But this month, the inevitable happened: 

 it was developing its own AI tools, including Art, an AI scribe that will, like other apps, share medical information with clinicians in real time. It’s part of Epic’s “native AI charting” developed in partnership with Microsoft, and is expected to launch for “limited use” early next year, a spokesperson from the company told Healthcare Brew and other outlets.

So what will happen to the scribe startups when the EHR giant releases its own AI tools?

Experts told Healthcare Brew they expect some market shift, but think their technologies provide strong value to providers.

“I wouldn’t be a very good founder if I didn’t think this was already going to happen,” Tom Kelly, co-founder and CEO at AI scribe developer Heidi Health, said.

You may have noticed, but Epic isn’t only releasing an AI scribe. It’s looking to build a suite of AI tools to help everywhere from the patient room to the back office, according to the company.

This highlights a bit of a trend in the health tech industry: Execs don’t want to just make scribes; they’re instead hoping to automate the entire healthcare workflow.

In fact, Ambience Healthcare—one of the leading AI scribe developers in the US, with at least 40 clients like the Cleveland Clinic and the Houston-based Memorial Hermann Health System—made its own expansion announcement, entering a $243 million Series C fundraising round on July 29.

Then on Aug. 19, Ambience released an AI copilot tool, Chart Chat, which works within Epic to provide real-time health information to clinicians, like lab results and prior treatments.

“We still feel like we’re 5% of the way through everything we possibly want to build,” Nikhil Buduma, Ambience’s co-founder and chief scientist, told us.

AI healthcare company leaders are also confident in their technologies.

The two co-founders said they think Epic will provide an accessible—and possibly cheaper—internal solution, which may be better suited for an outpatient facility. But Buduma said academic medical centers may want something more high tech since they tend to care for more patients and handle more complex cases that require added clinical integration.

It’s also important to differentiate between competitors.

For example, Kelly said Heidi Health is focused on building a tool that can be used in Epic but isn’t necessarily 

 to be. This means it can also complete tasks, like helping with forms outside of the medical record, in addition to its note-taking capabilities, Kelly said.

AI scribe companies also have existing contracts with providers. Ambience and Cleveland Clinic signed an agreement for five years back in February, for instance.

Just because Epic has its own scribe now doesn’t mean these partnerships will disintegrate, the two co-founders said. Buduma said Ambience plans to work with the Cleveland Clinic while further developing its products.

Still, Kelly said he “would never want to let an agreement be the thing that keeps [Heidi’s] customers” adding it’s the health tech company’s responsibility to build an integrated product “that makes it really hard to swap” for another tool.

Where he could see companies running into problems, though, is when their value proposition is their integration with Epic. If Epic is cheaper, doesn’t require additional authentication, and there’s no data-sharing risk, “then it probably will be actually quite easy for [health systems] to swap,” Kelly said.

When contract renewals come around, he expects to see some lower prices because of this. There could also be more 

With this competitive market and increasingly high-tech products, Epic’s announcement "definitely will heat up the market,” Kelly said.

Robot typing text on a typewriter. Artificial intelligence generated text and future of journalism concept. Vector illustration.

How the AI scribe market may—or may not—shift following Epic’s AI tool launch 

AI scribe experts tell us they’re not too worried about Epic launching new AI tools. 

Welcome back to AI 411, a monthly roundup of artificial intelligence (AI) announcements from across the healthcare industry.

 its new suite of AI tools, including integrating an ambient scribe into the electronic health record (EHR) giant’s platform. (We spoke with other AI note-taking platform startups to see how they’re feeling about the news.)

Here’s the rundown of health-related AI updates from around the industry in August.

 Smart hospital company Artisight announced Aug. 28 it can now autonomously document operating room activity into EHRs. The tool could 

 on clinicians and also prompt staff to do things like scrub up when a patient enters the room. Similar tools from the company are already used in patient rooms at health systems like York, Pennsylvania-based WellSpan and Chicago-based Northwestern Medicine.

, or CHAI, a nonprofit dedicated to responsible AI use, and the National Association of Community Health Centers (NACHC), which represents community health centers (CHCs) serving nearly 34 million patients, announced a new partnership Aug. 14. Through policy, education, research, and integration support, the pair said in a release they hope to ensure CHCs and patients “are prioritized and positioned to benefit” from AI in healthcare.

On Aug. 20, EliseAI, which automates healthcare and housing systems like multistep scheduling and prior authorizations, announced a $250 million fundraiser. The Series E round was led by venture capitalist (VC) firm Andreessen Horowitz and had participation from other VCs, including Bessemer Venture Partners, Sapphire Ventures, and Navitas Capital. Funds will be used to hire more staff, according to a release. The company’s valuation has doubled to $2.2 billion since last August, 

Mental health company Grow Therapy announced a new AI feature on Aug. 19. Called “between-session reflections,” it provides a space for clients to write about their thoughts and feelings between appointments. The reflections are organized into themes they can access privately, and they can choose what they'd like to share with their provider.

Infrastructure software company Medallion, which uses AI to automate the back office of healthcare, announced $43 million in new funding on Aug. 18, bringing its total funding to $130 million. The round was led by VC Acrew Capital, and had participation from other firms, such as Washington Harbour Partners, Sequoia Capital, GV, Spark Capital, and NFDG. Among other things, the company is using the funding to launch CredAlliance, a tool designed to speed up and reduce administrative burden around the credentialing process for health insurance companies, according to a release.

On Aug. 13, EHR provider Oracle Health announced a “next-generation” platform, which includes implementing an AI agent to be an “intelligent clinical assistant” in the software, according to the company’s website. The tool automatically drafts clinical documentation, enables voice search, and provides patient summaries to help clinicians prepare their workflows.

assortment of various medical devices around a teal healthcare symbol

AI 411: August 2025

Your monthly roundup of AI announcements is here.

It’s been more than five years since the arrival of Covid-19, which has led to the deaths of 1.2 million in the US and 7+ million around the world, according to the 

Readers may also remember another crisis that emerged alongside the pandemic: pediatric mental health.

From March to October 2020, emergency department mental health visits rose about 24% among children ages 5–11 and around 31% among ages 12–17 from the year prior, 

. Suicide attempts also rose nearly 51% among teenage girls in 2021 compared to 2019, the 

At that time, there weren’t enough providers to meet the increased need, an issue the industry has reckoned with 

 leading up to the pandemic. As a result, many young patients ended up 

 in the ER to be admitted to inpatient care.

To help address this need for care, several new behavioral health startups popped up during the pandemic. While not all of them made it—like 

—others, like InStride Health and Brightline, are still going strong.

“It was very clear that what was in existence at the time was not sufficient to meet the needs of kids and families,” InStride Health co-founder and Chief Medical Officer Mona Potter told Healthcare Brew.

Christine Crawford, associate medical director at the National Alliance on Mental Illness, told us there was a youth mental health crisis before 2020, but the pandemic made it worse.

“The system was already quite fragile—and fragmented—prior to the pandemic,” she said. But due to social distancing practices and a loss of social activities, there was a “worsening of mental health symptoms.”

Naomi Allen co-founded California-based Brightline, which provides in-person and online appointments, in 2019. She already had 10 years of experience in executive leadership for new digital health companies, including Castlight Health and Livongo, helping adults with care navigation and chronic disease management.

But Allen pivoted to pediatric mental health when one of her children was in need.

“We just really struggled as a family to navigate the healthcare system,” she said. “We paid cash for everything. Most of our clinicians were out of network…and we sat on a waitlist for nine months.”

The idea was to establish physical clinics for in-person appointments with therapists and psychiatrists, supplemented with a digital platform for caregivers to help them do everything from scheduling appointments to following along to see how the child was progressing.

Brightline was getting ready to open its first clinic in Q1 2020 when the pandemic hit, so it shifted to online only. 

Across the country, another startup—InStride Health—emerged in 2021 for similar reasons. It was built out of McLean Hospital, a psychiatric facility in Massachusetts associated with Mass General Brigham.

Potter originally thought she would only work in academic medicine for her whole career, where she was developing “cutting-edge” treatments, like the McLean Anxiety Mastery Program (MAMP). This specialized treatment program launched in 2014 to treat kids with severe anxiety and obsessive-compulsive disorder using cognitive behavior therapy and group meetings.

Yet lingering were inquiries from families who needed help for their children but faced a four- to six-month wait list “at all times” due to limited participant capacities in academic medicine.

So Potter took MAMP out of academia and built the fully virtual InStride Health, which allowed her team to negotiate directly with insurance companies and design a technology platform.

That shift to telehealth was one of the pandemic’s long-standing impacts on healthcare. It forced providers to move from in-person to virtual care “in one day,” Potter said, creating a “natural experiment” for her team to collect data and evaluate its effectiveness.

From March to June 2019, only 0.3% of all medical treatments for working-age individuals were conducted via telehealth, but in the first three months of the pandemic in 2020, that portion shot up to 23.6%—a 766% increase, according to a 

In October 2020, Brightline also launched a Covid-19 behavioral health indicator, a 30-question survey, to help parents understand the impact of the pandemic on their child’s mental health, Allen said.

“We felt this immense need for moving with speed because we knew we were out in front and that families had a tremendous amount of need,” she said.

Brightline now has 550 employer customers across six states. It also launched in-person care, with one clinic in Brooklyn and two more under development in Manhattan and Long Island. By next year, Allen said she expects to have eight to 10 additional sites, but did not specify where.

InStride is fully active in 10 states, and Potter said the goal is to expand it to all 50. In 2025, the company enrolled 2,500 new patients.

Both companies also addressed out-of-pocket payment challenges patients previously faced, making sure their services are covered under some commercial plans.

Speaking of challenges, upcoming Trump administration 

 for LGBTQ+ youth are presenting additional hurdles to care, Allen said, as the 

Still, Allen said greater awareness in schools and among the public has made a difference. In 2022, KFF 

 of US residents think there is a mental health crisis in the country.

“If there is any silver lining coming out of Covid, it’s that the child and youth mental health crisis that existed already is certainly much more the national dialogue,” she said.

Close up of African-American psychologist taking notes on clipboard in therapy session for children