Artificial intelligence is already used widely in healthcare, but generative AI is a big — and somewhat risky — step forward due to rapid deployment of the technology paired with a lack of regulation and oversight, industry experts said at the HIMSS conference in Chicago this week.

As a result, tough ethical questions are dogging generative AI like GPT-4, OpenAI’s latest large language model that backs the premium version of the wildly popular chatbot ChatGPT. Still, generative AI has huge potential to help improve U.S. medical care, proponents say.

One of the biggest companies in the space, Microsoft, has been working with GPT-4 developer OpenAI over the last eight months to understand the technology’s implications for healthcare. Generative AI is showing early success in a number of use cases, including simplifying explanation of benefits notices and writing prior authorization request forms, Peter Lee, corporate vice president of Microsoft Healthcare, said in a keynote panel on Tuesday.

Physicians can give the AI prompts to help them interpret novel medical cases or rewrite a patient conversation in a standardized format, Lee said.

Microsoft recently unveiled plans to embed generative AI into clinical software from Epic, the biggest hospital EHR vendor in the U.S.

Last week, Microsoft and Epic went live with the first sites integrating GPT into EHR workflows to automatically draft replies to patient messages. The companies also are bringing generative AI tools to Epic’s hospital database, allowing laypeople to ask the AI general questions instead of needing a data scientist to query specific data.

Epic is investing a significant amount of R&D resources into generative AI, Seth Howard, Epic’s vice president of R&D, said in an interview.

The health IT company also is researching the use of generative AI to summarize a patient’s medical history, and translate patient-facing materials between different languages and reading levels, to improve health literacy.

“That’s kind of a big category of work,” Howard said. “There are many use cases we’ll put out over the next year.”

Google also is making its own large language model, called Med-PaLM 2, available to a select group of customers to explore use cases. Med-PaLM was specifically trained on medical data, allowing it to sift through and make sense of massive amounts of healthcare information. Still, it has room for improvement in the complexity of queries it can perform and meeting product excellence, according to Google’s AI team.

Med-PaLM won’t be used in patient-facing settings, Google Cloud head Aashima Gupta said in an interview. Instead, hospitals could use the AI to analyze data to help diagnose complex diseases, fill out records or as a concierge for patient portals.

One notable use case for generative AI is streamlining medical notetaking, experts say. Physicians can spend up to six hours a day logging notes in their EHR, which can result in cutting back on time with patients and contribute to burnout.

Leading clinical documentation companies are integrating generative AI technology that they say improve their products’ accuracy and speed.

Nuance, a documentation company owned by Microsoft, said last month that it had integrated GPT-4 into its clinical notetaking software. This summer, providers using existing Nuance documentation products can apply to beta test the application, called DAX Express.

Ten to 15 clients summing 300 to 500 physicians will test the product in private preview in mid-June, before it’s generally available in early fall, said Diana Nole, general manager at Nuance.

Suki, a documentation company that’s partnered with Google, launched its generative AI-powered “Gen 2” voice assistant earlier this month.

Now, Suki can generate a clinical note ambiently from a conversation and fill in the note automatically, CEO Punit Soni told Healthcare Dive. Closer to the end of the year, doctors will also be able ask the AI questions and give it commands, such as plotting a patient’s A1C levels over the last three months, Soni said.

Gen 2 currently is being piloted with “very few” customers, according to the CEO. Suki plans to make it generally available later this year.

”The interest is unbelievable,” Soni said. “If you could have somebody to just do all your notes for you — wouldn’t that be awesome?”

Weighty risks

To be sure, generative AI makes mistakes, raising pernicious ethical questions around accuracy, equity and accountability. That means the medical community needs to have a robust ongoing role in deciding whether, when and how this type of AI is used, experts said at HIMSS.

One issue with AI is the black box problem: How can a result be trusted if it’s unclear how the AI got there?

It’s easy to be fooled into thinking that this type of technology is able to reason, but users have to remember generative AI doesn’t engage in deliberation — just predicts the next set of words that makes the most sense, said medical ethicist Reid Blackman.

“Maybe we’re okay with magic that works. That’s one option. The other option is to say okay, if you’re making a cancer diagnosis, I need to absolutely understand the reasons why you’re making that diagnosis… The problem is that GPT doesn’t give reasons. It gives what looks like reasons,” Blackman said on a Tuesday panel.

Generative AI also has issues with accuracy. Large language models are known to hallucinate, or provide answers that are factually incorrect or irrelevant. GPT-4 “still has many known limitations that we are working to address, such as social biases, hallucinations, and adversarial prompts,” OpenAI’s website reads.

Bias is another key worry with AI, especially in healthcare. If an algorithm is trained on biased data, or its results are applied in biased ways, it will reflect and perpetuate those biases, experts said.

Accountability also remains a concern. Since generative AI is such a new field, it’s unclear which stakeholder — the owner? the user? the developer? — is at fault for any negative consequences stemming from its use, according to Kay Firth-Butterfield, CEO of the Centre for Trustworthy Technology.

“Who do you sue when something goes wrong? Is there somebody to sue?” Firth-Butterfield asked during the Tuesday keynote panel.

More than 27,000 stakeholders have signed an open letter asking AI labs to immediately pause training AI systems more powerful than GPT-4 for at least six months. The letter argues that industry should use the moratorium to develop shared safety protocols and work with policymakers to develop AI governance systems.

“You shouldn’t be exploring, engaging in artificial intelligence, without having some understanding of responsible AI issues,” said Firth-Butterfield, who signed the letter. “We are hurtling into the future without actually taking a step back and designing it for ourselves.”

‘Mysterious,’ ‘awe-inspiring,’ ‘frustrating’

AI companies argue many of these problems can be ameliorated with careful human oversight. Organizations should be explicitly aware of the dataset a model was trained on and when precisely it should be used, experts said.

Microsoft’s Lee said while questions about generative AI are important, especially those around accountability, the black box problem might not be as troubling as some say.

“We’ve been unable to provide its incapable [of reason],” Lee said. ”It’s a mysterious and awe-inspiring and frustrating research roadblock that we’ve been unable to prove that. I have to admit, as a scientist, that this black box issue, at some point of development starting with GPT-4, actually might not really exist.”

And there are techniques to ensure generative AI gives a reliable output — a field called prompt engineering, where scientists figure out how to query the AI in a way that produces trustworthy results, Epic’s Howard said.

Both Suki and Nuance declined to share the accuracy rates of their generative AI-based notetakers, but said accuracy was high enough that they’re comfortable instituting them in a real-world setting.

Soni said Suki could publish its Gen 2 accuracy rates in a few months. And Nuance has been working with AI for years, Nole said.

“The level of accuracy we were already producing is advanced. We know how it works. We know how it acts. Now, we’re just utilizing GPT to kind of raise the level,” Nole said.

As AI has advanced, some models have outperformed doctors on diagnostic tasks, creating concerns that machines could one day replace clinicians. Experts at HIMSS agreed that day is nowhere close, even with generative AI.

Med-PaLM’s ability to pass a medical exam is “in no way indicative of medical knowledge or competence,” Alan Karthikesalingam, Google’s health AI research lead, said in an interview.

“There are a lot of material safety, bias and ethical concerns that need to be attended to very carefully,”  Karthikesalingam said. But replacement? “I think by and large that on its own is hopefully not a huge concern to us physicians. The positioning of these systems is very much as tools.”

Suki and Nuance stressed that their AI-created notes allow clinicians to edit and approve what is finalized in the EHR. Generative AI is an instrument for doctors, not a substitute for them, AI executives said.

Still, “anyone who can make predictions on what this epoch will bring is a fool,” Soni said. “What I can tell you is that in the foreseeable future, I see AI being a very strong and serious assistant that makes a lot of our lives better.”

Hacking healthcare:

With 385M patient records exposed, cybersecurity experts sound alarm on breach surge

Cybersecurity experts say healthcare companies must harden their defenses, but it may require regulators and lawmakers to raise the bar on security standards.

Published March 9, 2023 • By Samantha Liss and Jasmine Ye Han

Healthcare companies more than ever are using electronic records and tapping digital services. That’s also creating more opportunities for cybercriminals — who already have exposed the private medical information of millions of patients — and bolsters the case for the industry to make security priority No. 1, experts say.

Healthcare breaches have exposed 385 million patient records from 2010 to 2022, federal records show, though individual patient records could be counted multiple times.

Hacking incidents, a type of breach, at healthcare firms have skyrocketed in the past five years as cybercriminals demand ransoms in exchange for restoring access to sensitive medical data.

Hacking or IT incident is the most common breach type

Other types include unauthorized access/disclosure, theft, loss, improper disclosure, other and unknown.

While healthcare companies have to improve their cybersecurity given the rise in breaches and cyberattacks, regulators need to raise the bar on cybersecurity standards, experts told Healthcare Dive.

"Could all these organizations do a better job? Absolutely," said Jim Trainor, former assistant director of the Cyber Division at the Federal Bureau of Investigation and who is now a senior vice president of Aon Cyber Solutions, a global professional services firm.

Disrupting any one of the nation's 16 critical infrastructure sectors, including the healthcare industry, poses a national security threat. These sectors are vital to daily life for millions of Americans and disabling them would have a debilitating effect on society, according to the Cybersecurity and Infrastructure Security Agency, or CISA, the country's cyber defense agency.

Cyberattacks that disrupt hospital operations put patients' lives at risk. The FBI said that the healthcare industry was hit the hardest by ransomware attacks in 2021 compared to other critical infrastructure. And the threats come as hospitals struggle with staffing shortages and financial pressures exacerbated by the COVID-19 pandemic.

In the wake of a ransomware attack on one of the nation's largest hospital operators last year, Healthcare Dive analyzed more than 5,000 breaches reported over the past 13 years to the HHS Office for Civil Rights, the agency tasked with enforcing privacy and security laws in the healthcare sector.

A breach is a broad term for when protected health information that can identify patients is improperly revealed or used. A hacking or IT incident is a type of breach that involves a technical intrusion, according to the HHS, and is just one type of breach tracked by the agency.

0

The number of breaches has increased almost every year since reporting first began in 2009. Healthcare Dive confined its analysis to breaches that affected more than 500 people in each incident.

The number of breaches reported each year more than tripled from nearly 200 in 2010, the first full year that data was available, to more than 700 in 2022.

More than 52 million people* had their private health information exposed in 2022 in more than 700 breaches, up from about 6 million people in 2010.
*One person could be counted multiple times if exposed in multiple breaches.

The upward trend is more apparent if the 2015 Anthem breach is excluded.

The size of each breach — or the median number of people affected in each incident — has also jumped since 2018. The median is the midpoint between the largest and smallest breach and is less distorted by outliers.

Last year, the median breach affected more than 6,200 people, more than twice the size of the median breach in 2018.

Breaches can dramatically range in size in terms of the number of people affected in each incident.

The vast majority of reported breaches affect fewer than 65,000 people.

The second-largest breach disclosed since reporting first began in late 2009 affected 11.5 million individuals.

The largest reported breach occurred in 2015 and exposed the private health information of almost 79 million people through a cyberattack against Anthem, one of the nation's largest insurers. An investigation by regulators found that Anthem, now known as Elevance, did not have adequate protections in place to ward off cyberattacks. Anthem later agreed to pay a $16 million settlement with HHS OCR.

Cyberattackers infiltrated Anthem's IT systems through spear phishing emails sent to an Anthem subsidiary. Attackers stole patient information including full names, social security numbers, addresses, birth dates, emails and employment information, according to HHS OCR.

Health insurers, providers, clearinghouses and business associates are required to notify the HHS OCR when breaches occur. If a breach affects the private health information of more than 500 people, covered entities have 60 days to notify regulators.

The rise in breaches comes as healthcare companies have increasingly adopted digital services over the past decade, leaning more heavily on health information technology.

The use of electronic health records by hospitals, especially, has soared since 2010, when providers began to take advantage of federal incentive programs that made billions of dollars available to those that opted to use EHRs.

EHR adoption rate jumped to almost 100% within four years

Still, that connectivity can lead to cyber vulnerabilities and create avenues to access protected data, they said.

During just one episode of care, multiple entities may access a patient's information, including doctors, hospitals, X-ray facilities and insurance companies, Aon Cyber Solutions’ Trainor said.

"The complexity of the network to facilitate the events is unbelievable," Trainor said.

A rush to remote work fueled more entry points for attackers

The hospital sector became even more vulnerable during the pandemic, which dramatically accelerated the use of network- and internet-connected devices, said John Riggi, who advises the American Hospital Association on cybersecurity and risk. As non-clinical employees pivoted to working from home, hospitals increased their reliance on third-party and cloud services.

It led to an "expanded digital attack surface," said Riggi, who previously served as an FBI section chief overseeing cyber issues.

Hospitals' dependency on third-party technology also makes them more vulnerable because they don't have total control over the security of third-party tools, Riggi added. As a result, hospitals have to wait for vendors to send patches for connected medical devices and are prohibited from patching problems themselves.

“

The chain is only as strong as its weakest link and there are so many weak links.

Israel Barak, chief information security officer at Cybereason

”

"The key is we are being attacked by foreign adversaries. The vast majority of compromised records are from hostile acts, meaning foreign-based adversaries that even the FBI can't put their hands on," Riggi said.

"It becomes very, very difficult to secure this expanded attack surface under increased fire during a pandemic," Riggi added.

Israel Barak, chief information security officer at Cybereason, a cybersecurity firm based in Boston, added that many healthcare companies lack robust cybersecurity programs.

"The chain is only as strong as its weakest link and there are so many weak links," Barak said.

This makes healthcare an easy and profitable target for cyberattackers, he added.

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When breaches do occur, "the blast radius is bigger because of the information sharing," said Christina Powers, partner at West Monroe who leads the firm's Cybersecurity Advisory for Private Equity Program.

That may explain why the average breach size has surged in recent years, Powers added.

To be sure, not all breaches are the result of cyberattackers.

The federal government tracks a handful of breach types: hacking/IT incident, which can include cyberattacks; improper disposal; loss; theft; and unauthorized access/disclosure.

The second-most common type of breach in recent years is the result of unauthorized access or disclosure, which can occur when an employee accesses records outside of their job duties, according to Healthcare Dive's analysis. It can also include when patient information is exposed through misdirected communications.

Other types include loss or theft, such as when laptops or thumb drives are left in public places or stolen.

Rich data, profitable targets

Ransomware attacks are a top threat facing the industry because healthcare organizations are profitable targets, according to security experts.

In a ransomware attack, hackers lock out healthcare institutions from critical files and information and hold it hostage while demanding a payment in exchange for a decryption key to unlock the files.

Cybercriminals know healthcare organizations will feel pressure to rapidly restore access to lifesaving systems and technology.

Providers are more likely to pay a ransom when the disruption threatens patient care, such as when emergency rooms are shut down or when facilities are forced to reroute patients, Aon Cyber Solutions’ Trainor said.

The FBI has warned that these attacks can put patients at risk by delaying access to care and vital information.

A newborn died allegedly as result of a ransomware attack that disabled computers on every floor of an Alabama hospital and strained resources, according to The Wall Street Journal. The report said that Teiranni Kidd's daughter died months after she was delivered with the umbilical cord around her neck.

A 2021 survey of nearly 600 IT and health executives at provider organizations showed that ransomware attacks had a significant impact on patient care. Of those that experienced a ransomware attack, the majority reported longer lengths of stay; delays in procedures and tests; and diversions. More than one-third of respondents cited increased complications and almost one-quarter flagged increased mortality rates.

For ransomware criminals, 'it's all about ROI'

Ransomware attacks on healthcare organizations have increased in frequency and severity since 2016, researchers found and tracked through the database, THREAT, or Tracking Healthcare Ransomware Events and Traits.

"It's all about ROI" for these criminals, Trainor said.

In addition, it can be difficult to deter bad actors, who can launch attacks from other countries and are often outside the reach of U.S. law enforcement, according to security experts.

In September, three Iranians were charged with attempting to launch a cyberattack on Boston Children's Hospital, one of the largest pediatric medical centers in the country.

FBI Director Christopher Wray later characterized the foiled incident as "one of the most despicable cyberattacks I've ever seen."

While the FBI was able to intervene before the attack was committed, the incident raised concerns about nation-state attacks on healthcare operators in the U.S.

"I do think we need to be prepared about the possibility of disruptive or destructive attacks by nation-states on healthcare, too," said Morgan Demboski, a threat intelligence analyst for IronNet, a cybersecurity firm based in McLean, Virginia.

Attacks can be motivated by cyberespionage as well, Demboski added.

Some nation-states aimed to steal vaccine-related information and other medical research linked to the coronavirus to boost their own commercial sector, Demboski said.

Amid this threat landscape, healthcare firms should upgrade their cyber preparedness and may need a push from federal regulators, security experts said.

“

... the level of security across the industry is not where it needs to be to protect patients' healthcare information.

Jim Trainor, senior vice president of Aon Cyber Solutions

”

On March 1, President Joe Biden unveiled a sweeping national cybersecurity strategy that seeks to improve the nation's cyber defenses. The policy goal calls for establishing minimum cybersecurity standards across critical infrastructure, including the healthcare industry.

The policy plan, while not an executive order, will serve as a guide for federal agencies and lawmakers to enact cyber requirements.

Raising the bar on cybersecurity standards is critically important for healthcare companies, security experts said.

"I think we need to set a higher regulatory standard for healthcare organizations," Cybereason's Barak said.

To be sure, raising the bar will likely come with financial consequences for hospitals and may raise healthcare prices, Trainor said.

Still, Trainor added, "the level of security across the industry is not where it needs to be to protect patients' healthcare information."

Methodology

Healthcare Dive downloaded the health breaches dataset from the HHS (Archive -> Research Report) on March 2, 2023. The data serves as a living document, which the OCR may update after each investigation. Covered entities have 60 days to report breaches that affect more than 500 people to the OCR. Breaches involving fewer than 500 people may be reported on an annual basis and are not included in the downloadable data.

Dates of breaches mentioned in the charts refer to the date when a breach report was submitted.

News graphics developer Julia Himmel and visuals editor Shaun Lucas also contributed to this piece.

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Dive Brief:

• IBM on Monday unveiled the first quantum computer solely dedicated to healthcare research on-site at Cleveland Clinic.
• The IBM Quantum System One is also the first IBM-managed quantum computer in the U.S. not at one of IBM’s facilities, according to a release on the news.
• Academic medical giant Cleveland Clinic and IBM started a 10-year partnership in 2021 focused on advancing biomedical research through technology, including quantum computing and artificial intelligence.

Dive Insight:

Hospitals looking to leverage their reams of patient data for research and development have increasingly inked deals with technology companies. Cleveland Clinic and IBM signed their deal two years ago, which revolves in part around quantum computing, a faster and futuristic way of processing data.

The goal of the partnership is to streamline data collection and analysis to speed research into viruses and genomics, among other areas like population health, and spur the development of new tools and therapies for a variety of diseases.

The joint IBM-Cleveland Clinic venture also investigates new approaches to public health crises and looks for proactive ways to head off new pandemics, the companies said when the partnership was announced.

The partnership, which includes the use of two quantum computers from IBM, has resulted in multiple projects leveraging quantum computing in healthcare.

Those include developing quantum computing pipelines to screen drugs targeted to specific proteins; improving prediction models for cardiovascular risk following surgery; and applying AI to search genome sequencing findings and large drug-target databases to pinpoint existing drugs that could help patients with Alzheimer’s and other diseases.

Cleveland Clinic CEO Tom Mihaljevic in a statement called the unveiling a “pivotal milestone” in the academic medical center’s partnership with IBM.

Cleveland Clinic’s investment in installing the computer onsite is part of the $300 million commitment the system is making into the Cleveland Innovation District, a spokesperson said. The Innovation District is a project launched in January 2021 with three hospital systems partnering with two universities on research and new projects.

IBM also plans to install a more powerful next-gen quantum system at Cleveland’s campus in roughly three years, though those computers are still in development.

Quantum computers process information in a fundamentally different way than current computers, allowing them to test multiple solutions to a single problem at the same time. That results in exponentially quicker processing speed and faster results, which could go far in expediting the lengthy processes involved in medical research and the development of new pharmaceuticals.

Currently, research suggests it takes an average of 17 years to get a drug to a patient from the moment of scientific discovery.

Along with streamlining clinical trials, quantum computing could optimize back-end functions for payers and providers, saving hundreds of billions of dollars. Experts expect quantum computing to be used in practice as early as the next few years.

Amazon’s $3.9 billion acquisition of primary care company One Medical was finalized last week without a regulatory challenge. Consumer protection groups say the deal shouldn’t have been allowed to close, citing a number of concerns — some of which are shared by the Federal Trade Commission.

The agency, which reportedly had prepared a lawsuit to block the deal, could still sue to unwind the transaction farther down the road. Still, antitrust and M&A experts said that if regulators had found a reason to block the deal, they already would have.

“The government needs to be careful on where it’s meaningful to stir up anti-competitiveness and where it’s not. The head-fake on concerns here really raised a lot of eyebrows,” said Nathan Ray, healthcare M&A lead at consulting firm West Monroe.

Amazon’s strategy and data concerns

Amazon has made some bold investments in healthcare, but acquiring One Medical represents a new facet of the e-commerce giant’s healthcare strategy with the operation of physical medical clinics. The transaction brings more than 220 medical offices in 27 U.S. markets, a subscription telehealth service, an electronic health record and contracts with 9,000 employers under Amazon’s umbrella.

It’s a ripe time to disrupt the primary care market, according to analysts. An aging population, the growing prevalence of chronic conditions, rising healthcare costs and difficult care access are increasing demand for convenient, cost-effective access to healthcare close to the home.

That’s fueling a frenzy of deals in the space from acquirers ranging from CVS Health to Walmart to Best Buy, experts said.

“There’s a tremendous opportunity to make a profit,” said Natalie Schibell, a healthcare research director at market insights firm Forrester.

Analysts expect One Medical to continue operating independently within Amazon in the near term, as Amazon works to shore up back-end operations and connect the primary care company to its larger ecosystem of pharmacy and retail capabilities.

Amazon could take steps like connecting One Medical membership to Prime, its paid subscription service used by an estimated 168 million Americans, although it’s unlikely it will completely reinvent the provider’s business model, Ray said.

To be sure, consumer advocates have expressed concerns about the tie-up.

Consumer protection group Public Citizen urged regulators to block the deal after it was announced last summer, saying it had “grave concerns” about Amazon acquiring One Medical in a letter to regulatory groups.

Public Citizen said Amazon could leverage its dominant role in the online retail market to gain an unfair advantage in healthcare. By bundling One Medical and Prime membership, Amazon could create new revenue streams distinct from the provision of healthcare, such as targeting product advertising related to medical conditions, the letter says.

“What connects most or all of our concerns is the idea that Amazon can leverage its massive retail market power into the healthcare sector for nefarious purposes,” Rob Weissman, the president of Public Citizen, said in an interview. “It’s a very, very problematic merger, but the kinds of concerns it raises don’t line up perfectly with antitrust law.”

Another big concern revolves around Amazon acquiring, and potentially misusing, One Medical’s patient data.

Amazon already gathers a vast amount of consumer data through its online marketplace, Prime video and music platforms, Alexa voice assistant, Ring doorbells, fitness trackers and more. The company uses that data, including inferred health status, to direct individualized advertising and content suggestions.

Acquiring One Medical’s actual health records from its 836,000 members could make those inferences a lot easier. That data is of “extraordinary value to a marketing company such as Amazon,” Public Citizen said.

Amazon has said it will comply with the Health Insurance Portability and Accountability Act, which governs what healthcare companies can do with protected health information. That means Amazon can’t share One Medical customers’ personal health data outside of One Medical for advertising or marketing purposes without their clear consent.

Still, Amazon could find workarounds like securing privacy waivers from One Medical consumers by offering a Prime discount, Weissman said.

”Every corporation is supposed to follow the law. That’s not the issue. You don’t get points for saying you’re going to follow the law,” Weissman said. “HIPAA protections are really hardcore, but there are a lot of ways to work around it. As a consumer, you should take zero comfort in that promise.”

Public Citizen’s concerns are shared by at least two FTC commissioners.

On Monday, Commissioner Alvaro Bedoya issued a statement co-signed by Commissioner Rebecca Kelly Slaughter calling out HIPAA’s limitations in protecting health data and urging Congress to enact more modern privacy laws.

“When you hear a company tell you that they will abide by HIPAA, it does not mean that they cannot use your data for other purposes,” Bedoya wrote. “When HHS proposed the Privacy Rule in 1999, I doubt that it had reason to anticipate that one day the world’s largest retailer — a company of profound technological sophistication — would amass people’s health information on this scale.”

Analysts said that data acquisition was likely a big driving factor for the deal. After linking One Medical's data with that from its other products and services, Amazon can analyze petabytes of healthcare data in the cloud and use the findings to better manage the health of One Medical’s Medicare population, build new products and pinpoint people with rare diseases to solicit participation in clinical trials, according to Forrester’s Schibell.

While concerns about data misuse are real, Amazon can mitigate them by implementing stringent security protocols and communicating privacy policies or consent for data use in clear language, Schibell said.

Amazon has a ways to go in gaining consumer trust. Over a third of U.S. adults say they’re not at all comfortable using Amazon for their healthcare needs, according to a Forrester survey from 2022 shared with Healthcare Dive.

“If they blow it — if there's a major security breach, if they go about this the wrong way, and they're not transparent, if they don't appear to be serving the best interest of the consumer and population health — that's where you'll only recede on trust,” Schibell said.

Next steps for FTC

Regulatory experts said the FTC performed a stringent review of the merger, even requesting additional data from Amazon and One Medical. Among other concerns, regulators were looking for ways the deal could substantially eliminate competition, remove a head-to-head rival or create stronger incentives to leverage market power in a new market, according to Diana Moss, president of the American Antitrust Institute.

The FTC didn’t touch the deal after its review because it didn’t find a sensible theory to do so, Moss said, noting that the Biden administration has proven it’s willing to be aggressive and creative in interpreting statute to halt deals it views as anticompetitive.

“We have antitrust chiefs at the FTC and the DOJ that are very willing to push the envelope on bringing more cases, bringing more novel theories of competitive harm,” Moss said. “If you ever had an antitrust agency that was willing to bring more cases on more novel theories of harm, it would be the current enforcers without a doubt. That leads me to believe when they looked at Amazon-One Medical, they were absolutely looking at non-conventional theories ... If they weren’t able to patch together a novel theory of harm, then that tells you something.”

The FTC is continuing to monitor the deal. One agency official told Healthcare Dive that regulators still have competition concerns, because One Medical is a dominant player in the primary care space, and its acquisition by Amazon could allow it to grow in an anticompetitive fashion.

The FTC is also concerned about consumer protections, regarding patients potentially handing over sensitive medical information to One Medical, not expecting it to be used for other purposes such as marketing or advertising, the official said.

Still, circumstances would have to change for regulators to try to unwind the deal, such as proof that Amazon is systematically mishandling One Medical patient data, antitrust experts said.

In addition, unwinding a transaction is significantly harder than blocking one and challenges to consummated mergers are exceedingly rare.

“They’ll seek to unwind the deal only if Amazon acts totally contrary to its own interests and the fundamental philosophy of its own business,” which is a strong recognition of consumer sovereignty, said David Balto, an antitrust attorney and the former policy director of the FTC.

“I think at the end of the day Amazon has a compelling case that consumers are better off when they expand into various markets,” Balto said. “Certainly competitors in these markets don’t welcome Amazon stepping to the plate, but consumers at the end of the day may be better off.”

Amazon sent shockwaves through the pharmacy industry when it launched its online pharmacy business three years ago, though at the time, experts were split on how disruptive the venture would prove for incumbents like CVS and Walgreens.

Now, a top leader at Amazon Pharmacy says the business has evolved in the past three years — and in the past three months, after announcing a new generic drug subscription for Prime members and manufacturer coupons for select brand name medications — though the business is still finding its footing.

Healthcare Dive caught up with Vin Gupta, Chief Medical Officer of Amazon Pharmacy, at the HIMSS conference in Chicago on Tuesday. Gupta, a pulmonologist who’s been with Amazon since 2020 and joined Amazon Pharmacy in January, said that the business still has work to do educating providers on Amazon’s options for prescriptions. He also teased updates to affordability initiatives and shared his thoughts on how Amazon’s acquisition of primary care chain One Medical fits into its pharmacy strategy.

This interview has been lightly edited for clarity and brevity.

HEALTHCARE DIVE: How is the Amazon Pharmacy of today different than three years ago?

VIN GUPTA: After the PillPack acquisition we focused on polychronic — how do we make it as easy as possible for those with multiple conditions to take their medications. Now, from a versatility standpoint, just in the last three months we’ve launched RxPass — a Prime membership benefit for $5 a month with free delivery and access to over 50 different medications — and manufacturer coupons.

We’ve seen a lot of traction. We’ve experienced double-digit growth just over the last 12 months. We think that’s largely been driven by not just our DTC channels, but our partnerships. We work closely with PBM Prime Therapeutics and a variety of different insurance plans through them, and are working more closely with providers. And that’s resulted in what has been really sustainable growth.

What other affordability initiatives is Amazon working on?

GUPTA: Manufacturer coupons. It’s a concise list, but it’s a list that we plan to grow. It’s currently eight medications for conditions with large unmet needs. We’re really trying to focus on partnerships directly with manufacturers to expand that offering. That’s a key focus of 2023, and we’ll have more to share in the next couple of months.

With RxPass, there’s been a lot of positive uptake. But it’s a formulary that we don’t view as necessarily concrete. We’re continuing to revisit whether any changes need to occur there to make it pertinent and valuable to as many people as possible. 

There’s been some speculation that RxPass might not result in meaningful savings for consumers, given Amazon Pharmacy already offers inexpensive generics. What’s your take?

GUPTA: For the subsegment of individuals who have chronic disease, who might not have robust healthcare coverage, we do think that RxPass provides disproportionate value. Do we think that we’re solving all of the systemic ills in our healthcare delivery system with this offering? Of course not. But I do think that this is an incremental step towards affordability and transparency in drug selection.

Just a small fraction of Prime members use the subscription because of Amazon Pharmacy. Why do you think that is, and how are you addressing it?

GUPTA: Provider awareness is important when it comes to where a patient is designated to get their medications filled. So we’re actively ensuring that my peers, providers across the country, are aware of our services. Whenever I have conversations with my colleagues, they had no idea that Amazon Pharmacy provides this type of visibility into various ways patients can pay, and what that means for bottom line costs. At the heart of it, it’s education. It’s building awareness that we exist.

How are you building awareness?

GUPTA: There’s definitely a word of mouth component. I’ve had several conversations with provider groups. What we hear from them is, tell us more about what this means for our patients. There’s a lot of curiosity. And that curiosity has really spiked. It’s often patients bringing it up to providers, but now provider groups are coming to us proactively and saying, tell us what you’re doing that’s different.

It’s been somewhat bespoke, in terms of us having conversations with interested provider groups. To me, they feel quite collegial and collaborative, on what are the needs right now when it comes to patients across demographics? How are those needs being met from a pharmacy standpoint? And where can we plug in?

Does Amazon direct Amazon provider businesses, like One Medical and Amazon Clinic, to nudge patients to fill prescriptions through Amazon Pharmacy?

GUPTA: With One Medical, it’s just like other provider groups that are not part of Amazon Health Services. One Medical is a provider group that we’re talking to and having conversations with, no different than what we’re talking about with large healthcare systems or another telemedicine company. What do you feel is the biggest pain points in the pharmacy experience for patients? How can we potentially better serve?

But I’ll take off my Amazon hat, and put on my clinical hat, to say that at the end of the day, we still believe in patient choice. It’s important for patients to have choice in where they get their care, and where they fill their prescriptions. We just want to make sure that we are top of mind.

Are you concerned Amazon Pharmacy, if successful, could decimate community pharmacies like Amazon’s ecommerce site did with bookstores?

GUPTA: Many of my patients go to small and medium-sized pharmacies run by families, because they love that interaction with a pharmacist that they know. We believe that we are one stakeholder among many stakeholders that are trying to reinvent an experience. There’s always going to be a place — I firmly believe it’s important to have a place for small and medium-sized organizations within the pharmacy space because some patients prefer that. And we need to nurture that.

David Feinberg has worn multiple hats in his three decades in healthcare, including chief executive of major health systems UCLA and Geisinger and leader of Google Health. Most recently, Feinberg stepped up as CEO of EHR company Cerner in 2021, as the vendor looked to reorient from a focus on legacy EHR systems to becoming a software-as-a-service business.

A few months after Feinberg started, Cerner announced it was being acquired by software giant Oracle, for $28.3 billion, as Oracle looked to expand its cloud business in the hospital market.

Healthcare Dive chatted with Feinberg — now chairman of Oracle Health — at the HIMSS conference in Chicago about the company’s integration, Oracle’s progress in creating a national health records database and Cerner’s plan to help auto-adjudicate payment disputes between payers and providers.

This interview has been lightly edited for clarity and brevity.

HEALTHCARE DIVE: Oracle closed its buy of Cerner in June, calling it an anchor asset as Oracle elbows further into the healthcare space. How has the integration gone?

DAVID FEINBERG: It’s gone way better than I thought. My bias is oftentimes technology companies think those of us in healthcare are not really sophisticated, and if we did things their way things would get better. Oracle has been the exact opposite. So the integration has been pretty smooth. I think part of the reason is that two-thirds of the people at Oracle are there via acquisition, so Oracle knows how to do this.

I think there’s great excitement for what Oracle can bring from a technology standpoint, coupled with Cerner’s long-standing history of partnering with health systems around the world. The timing just feels right.

When the deal closed, Oracle said it planned to focus the unit on medical software usability and voice-enabled user interfaces, and would expand Cerner’s business to more countries. Can you give me an update on these priorities?

FEINBERG: I remember those three things being listed. It’s more now. Our vision is to create a cloud-enabled health platform that brings all kinds of information together to make individuals and communities healthier around the world. That includes the electronic health record, and Oracle’s human capital management, enterprise resource planning, supply chain management, claims processing, clinical trials — so we have a platform that normalizes data and then tees it up for whoever needs it, a mom taking care of kids at home, or a government looking at public health issues.

Oracle founder Larry Ellison announced Oracle plans to build a health records database to link the thousands of separate hospital databases. How is this going?

FEINBERG: It’s going great. We have a new product we just launched called Seamless Exchange. A clinician gets a new patient, and this patient has records from multiple places. With one click, we take all of that information and we make a longitudinal story of that patient. In all that, there’s a lot of duplicate information — it may say 40 times that you had a knee surgery. So we de-duplicate it. And if that information’s from a trusted source, like another health system I trust, it automatically writes it into the record for me.

To Larry’s vision of everybody having their records available in a secure way, no one wants all their medical records, because I don’t want to see 900 times the same cholesterol level that I had drawn. So the first step in getting to that vision is organizing disparate data sets and making them accessible and useful, and it’s EHR agnostic through an API.

What are the next steps?

FEINBERG: I don’t ever want to be more visionary than Larry Ellison. But I think it’s even broader than what he’s saying. Because not only do I want my whole electronic health data, I want all information that’s applicable to my health. That includes social determinants, that includes claims processing, so many other pieces of information — like, if there’s a claim on me, but not a documented note, that shows I had a cardiac ablation. So it’s more than just your EHR information from multiple sources, it’s multiple sources of information that pertain to your health.

How will Oracle pull that additional data?

FEINBERG: Oracle Financial Services processes 80% or 90% of the world’s credit card transactions. All that is is an agreement between the merchants and the banks to let Oracle be in the middle and make that transaction happen. In healthcare, there’s so much friction between the payer and the provider. So they agree on a contract, and a patient comes in and gets care. The coding takes place on the provider side, it goes over to the payer side, and they deny. Why did that happen? They each interpreted the contract a little differently. That never happens with a credit card.

So we have the clinical data. Oracle Financial Services also does claims data. We think we can be the trusted intermediary between clinical care and the payment of clinical care in a way that dramatically decreases the cost, where both parties have the ability to see and agree on what’s happening.

That also gives us access to that very important at-scale claims data. That claims data now adds back into my vision on top of Larry’s of we need those data sources. So we think there’s a business in decreasing the friction in paying for care.

Dive Brief:

• Verizon is building a private 5G network at a new Cleveland Clinic facility in Ohio — one of the first projects in the U.S. where a hospital is being newly constructed with a 5G network embedded from the start, the company said this week.
• The Cleveland Clinic Mentor Hospital, scheduled to open in July, will explore a number of 5G-enabled capabilities in addition to bigger bandwidth, including patient check-in kiosks, enhanced digital displays and virtual reality for assisted surgery and imaging, according to the release.
• Verizon is not disclosing the cost of the project, but the company is implementing 5G in a service model so the hospital doesn’t have to provide upfront capital expenses, Gary Lynch, Verizon’s global practice lead for healthcare, told Healthcare Dive at the HIMSS conference in Chicago.

Dive Insight:

Verizon has installed 5G cells in VA facilities, some innovation labs and select floors in different health systems, but the Cleveland Clinic hospital represents the telecommunications provider’s first full 5G hospital installation, according to Lynch.

Telecoms companies like Verizon, AT&T and Sprint are racing to build out their 5G infrastructures and nab new commercial markets, including in healthcare. AT&T says it is the first provider to install 5G in a U.S. hospital through a deal with Rush University in 2019 — a project that cost the hospital roughly half a million dollars per building, its CIO said at the time.

5G technology can handle 1,000 times more traffic and is up to 10 times faster than today’s 4G LTE networks — equivalent to downloading an HD movie onto a cellphone in less than a second. That could bring a lot of value to hospitals, through facilitating increased use of telemedicine, firmer patient control over personal health information, streamlined hospital communications and lower costs, experts say.

“A 5G infrastructure is needed because we need more bandwidth,” Lynch said. “The 5G bandwidth, it’s like this massive superhighway.”

Verizon has seen demand for 5G from hospital clients increase over the past few years, but providers remain skeptical, with a number of systems electing to wait and see the results of 5G installation at peer systems before they decide on the technology, he added.

“It’s overwhelming interest from the health systems today. Still skepticism, though,” as providers are uncertain about the value of the new technology, Lynch said.

Lynch said Verizon has also seen a lot of interest in 5G from pharmaceutical and medtech companies, due to how it can help infrastructure monitoring in the manufacturing space by predicting product quality.

Dive Brief:

• On Monday, the HHS unveiled the first six networks that have been approved to be onboarded as qualified health information networks, or QHINs, under TEFCA, the government’s framework for a nationwide health information exchange.
• It’s been about a year since the Office of the National Coordinator for Health IT released TEFCA, or the Trusted Exchange Framework and Common Agreement. Now, Epic, CommonWell Health Alliance, eHealth Exchange, Health Gorilla, Kno2 and Konza — organizations that collectively cover a significant swath of American health records — have committed to become eligible and go live within TEFCA in 12 months.
• A number of additional organizations are readying themselves to apply into the voluntary framework, said Mariann Yeager, CEO of the Sequoia Project, ONC’s private-sector coordinating partner for TEFCA, at a Monday HHS event. “This is just the beginning,” Yeager said.

Dive Insight:

Interoperability is critical for national healthcare infrastructure, HHS officials said Monday, and improving it will bring down costs while also improving care delivery.

Bringing the new prospective QHINs on board is a great start to improving the U.S. healthcare systems’ interoperability, but there’s a lot more work to do to address the digital divide between well-resourced and struggling providers, a lack of connectivity with public health agencies, sparse information sharing between payers and providers and little patient access to their own information, ONC head Micky Tripathi said.

“Our vision is that TEFCA can get us out of the collective shared helplessness that we’re in,” Tripathi said.

The 21st Century Cures Act passed in 2016 required the government to create a set of foundational principles for health information exchange, under a contract establishing a technical infrastructure model and governing approach.

TEFCA’s goal is to create a simplified and standardized connectivity infrastructure for providers, plans, patients and public health agencies. The effort builds on the progress of national networks, state and regional health information exchanges that facilitate secure exchanges of millions of medical documents each day.

The Biden administration early last year finalized TEFCA and opened a window for organizations to apply to be designated as QHINs, or groups of organizations that agree to the same data sharing infrastructure. That connects them to one another and enables their participants, including providers, payers and public health agencies, to exchange health information across the country.

The six potential QHINs unveiled Monday have 12 months to be onboarded, but that work could be done by the end of 2023, Tripathi said. Some of the QHINs, including electronic health record giant Epic, had already announced their intention to join.

The number of QHINs isn’t set in stone. An HHS spokesperson told Healthcare Dive they “continue to receive interest from a diverse range of organizations,” including health information networks and EHR vendors.

But the six organizations alone cover a significant number of Americans. Though it’s difficult to pin down an exact number given the overlap in covered lives, collectively the QHIN applicants have networks that cover most U.S. hospitals and tens of thousands of providers, and process billions of transactions annually across all fifty states, the ONC said.

Moving forward, the ONC plans to announce additional QHINs when they're designated.

The COVID-19 pandemic kickstarted a rapid increase in adoption of healthcare technology, reshaping the bedrock of American medical operations and delivery. But as 2022 drew to a close, several factors suggested that technology adoption was slowing down, including a cooled landscape for digital health funding and a drop in virtual care utilization.

In addition, a flurry of cyberattacks and concerns over the privacy of sensitive medical data highlighted the hazards of new technology adoption.

Despite this, experts remain upbeat about the potential of technology to improve U.S. healthcare in 2023.

According to predictions from industry stakeholders, this year could represent an inflection point for real-world utilization of artificial intelligence, and standards could raise for health data privacy and cybersecurity. In addition, though investors are more cautious, funding will continue to be available for startups this year, and the telehealth industry will be held to higher clinical standards as it’s used more frequently in care delivery.

Digital health goes back to basics

After a volatile few years of record digital health funding followed by a painful market correction, health tech is going back to basics this year as investors prioritize safety over risk, experts predicted.

Digital health funding may still experience a slight drop compared to past years, but funding levels should stabilize in 2023, according to Credit Suisse analyst Jonathan Yong. Companies that have a pathway to profitability or are already operating in the black should attract the most interest as venture capitalists — with valuations down compared to the highs of the past two years — become more discerning.

“While growth is still important, there has to be a much stronger balance between growth and path to profitability,” Yong said. “VCs are going to be much more selective in their investment choices.”

That trend should benefit public companies with track records of stability, mature business models, steady growth trajectories and fair valuations, according to SVB Securities analyst Stephanie Davis. Such companies include data analytics company Health Catalyst, patient intake software provider Phreesia and revenue cycle management company R1 RCM, along with EHR companies like Veradigm, née Allscripts, and Nextgen, Davis said.

Mental and behavioral health should continue to be key areas for funding, Yong said. Despite the multitude of behavioral health companies in the space, employers and payers “are still looking for help here,” he added.

Family planning and femtech also are expected to draw in dollars amid a rising focus in women’s health accelerated by the Supreme Court’s decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization last summer.

Experts said they think healthcare companies will adopt tools more slowly than they did last year, as payers and providers are forced to be more selective in whom they work with given financial pressures and an abundance of point solution companies in the market.

Payers likely will allocate resources toward physician enablement and care coordination capabilities. Meanwhile, providers will invest in tools to reduce administrative burden on clinical staff and improve revenue cycle management, Yong said.

Digital health companies have the greatest near-term opportunity from the provider wallet, as hospitals and physician networks continue to adopt digital health technologies to streamline operations in a difficult macro environment, including data and analytics strategies and patient engagement products, Davis said.

Despite opportunities, this year still is expected to be tricky for digital health startups. Experts said persistent layoffs and consolidation is likely as it becomes harder for point solution companies to operate independently. In addition, companies that decide to raise funding in 2023 will likely have to make do with a down round, and may have a harder time getting funding as the year goes on and a higher rate environment pressures valuations.

“I’ve been hearing a lot of quiet down rounds lately,” Davis said. “And I do think the companies that are doing the down rounds are being very prudent to do so.”

Telehealth shifts to ‘more high-value’ care

Research suggests that telehealth use has been falling since it peaked in spring 2020. However, some telehealth experts predict that digitally delivered healthcare will continue to grow, with volume shifting from urgent care visits that popularized the modality to virtual care for chronic needs.

The drop in consumer utilization of telehealth has “been offset in a very, very significant way by a huge rise in the way clinicians are using telehealth” — like consulting specialists in other systems, delivering care for patients undergoing chemotherapy, or checking on patients after surgery, said Roy Schoenberg, CEO of Boston-based telehealth company Amwell.

Amwell has seen clinicians using telehealth for this “more high-value” chronic and longitudinal care increase every week, generating volume that Amwell expects to continue rising in 2023, Schoenberg said.

Telehealth is increasingly being used for “what most healthcare is about, which is chronic patient care, longitudinal patient care, rather than the whimsical occasional flu, which is a very, very small part of healthcare,” Schoenberg said. “When I look at 2023, I actually see a bull market for telehealth driven by the reimagination of how patients need to be cared for by clinicians.”

Virtual care will increasingly be held to the same clinical standards as in-person care, and this year will bring more emphasis on quality and safety, according to Teladoc Health CEO Jason Gorevic. Telehealth standards were a source of controversy last year, with some companies accused of operating as pill mills, resulting in regulatory scrutiny.

In addition, economic pressures and shifting consumer expectations will contribute to a decline in the number of digital health point solutions in the market, experts said, with Gorevic noting that he wouldn’t be surprised if half are acquired or shut down completely by this time next year.

2023 will also be a year of reckoning for care navigators, which educate patients about healthcare decisions or connect them to providers, but don’t provide actual healthcare.

“Employers are taking note and we expect to see a shift in buyer habits this year” as employers look for vendors that “resolve a need rather than steer the problem elsewhere,” Gorevic said in emailed comments.

An inflection point for AI

The healthcare sector has long been eying the potential for artificial intelligence in healthcare, but adoption of such tools in the real world has been slow. The number of randomized controlled trials, and the actual use of AI in medical facilities, remains small, but more evidence could start to emerge this year to help ease adoption, Google Chief Clinical Officer Michael Howell predicted.

“What I think we’ll see with this in 2023 is we’ll start to see some high-quality evidence come out about the impact of AI and ML on actual health outcomes and on healthcare processes,” Howell said. “The question I always get is, ‘Will AI ever replace doctors and nurses?’ No. But will it start to augment and support them? I think we’ll start to see real examples of that.”

The Food and Drug Administration has been accelerating approvals of medical artificial intelligence tools, authorizing more than 520 devices as of November.

As more devices are approved, more providers will weave AI into their operations for uses in revenue cycle management, clinical decision support and patient engagement, experts predicted.

Payers will also look to find efficiencies using technology and discover new ways to use data they collect, as healthcare organizations struggle with the growing disconnect between consumer expectations and the reality of the healthcare experience — and competition from market entrants like Amazon and Walmart, according to a report from digital consulting firm West Monroe.

Healthcare companies get serious on cybersecurity, privacy

As healthcare organizations continue to adopt technology, attack surfaces will expand, increasing the need to secure the cyber environment, according to Chris Bowen, founder and CISO at data security firm ClearData.

For example, the number of ransomware attacks on hospitals more than doubled between 2016 and 2021, according to a recent study. Researchers estimated more than 42 million patients’ data was exposed over those five years.

As a result of rising incidents, healthcare organizations will increase their cybersecurity budgets, in some cases by more than 15% compared to 2022, Bowen predicts. Federal law enforcement also may become increasingly aggressive in combating cyberattacks, especially ransomware.

In addition, policymakers may get more serious on data protection laws as biometric and AI-driven healthcare technologies become more pervasive, according to Bowen. The lack of a comprehensive federal data privacy legislation is viewed as a major oversight in today’s digital age, and the HIPAA privacy legislation has notable gaps in the data it protects.

“It's unsettling that mobile app creators can collect health-related data that does not have federal data protection,” Bowen said.

Google’s Howell agreed that data protection and trust will be pivotal this year as a national conversation around privacy sparked by the overturning of Roe v. Wade stretches into 2023. In the wake of the ruling, a number of period tracking apps, data brokers and tech companies like Apple and Google took steps — often under regulatory and public pressure — to enhance privacy and security protocols.

Companies that operate in the healthcare industry will continue working to ensure patient data is kept secure and build trust with patients wary over the collection and use of their sensitive medical data, according to Howell.

“We will keep focusing on those,” Howell said.