News roundup: ONC recommends ‘nutrition labeling’ for healthcare AI apps but Google moves forward; CVS’ health services rebranding as Healthspire (updated); Clover Health repots out of ACO REACH

Straining toward a model for AI app information? The latest grope by Federal regulators towards the “trustworthy use of artificial intelligence”, as the American Telemedicine Association terms it, is a labeling system that has been likened to ‘nutrition labeling’. This near-incomprehensible analogy to food labeling was proposed back in April by the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC), now headed by Micky Tripathi, Ph.D. This disclosure would consist of how the app was trained, how it performs, how it should be used, and how it shouldn’t, which does not sound onerous at all. The disclosures are designed to forestall issues around performance and bias that have previously appeared, such as Epic’s AI system designed to predict sepsis risk and an algorithm designed to flag patients needing assistance with complex treatment regimens. 

An optional proposed disclosure around how the app was trained and tested would be important to healthcare organizations but potentially problematic to developers. There are quite a few caveats expressed by Silicon Valley investors around hurting startups and even giants like Epic through over-disclosure of proprietary information, enabling reverse engineering and poaching of intellectual property. Everyone likes transparency, trust, safety, and efficacy, but the conundrum is to disclose what is needed for proper and cautious use without providing an entreé to IP. Wall Street Journal, Becker’s, ATA release and AI principles 

Google, predictably, damns the torpedoes, full speed ahead with healthcare AI. And intends to write the rules. They’ve deployed AI tools already with Mayo Clinic and HCA Healthcare–Mayo for medical records and research papers, HCA for clinical notes. EHR Meditech is using Google’s AI for clinical documentation and to summarize patient histories. Bayer is also working with Google. Their products include a licensed algorithm for breast and lung cancer detection, a tool for diagnosing diabetic retinopathy, and a question-answering bot. Google makes no secret that they plan to influence Federal efforts at setting standards by hiring lobbyists, most of whom are out of the Food and Drug Administration (FDA), and playing a large role in industry groups such as the Coalition for Health AI (CHAI).  If you believe that Google, Microsoft, Amazon (playing catchup), or other healthcare service companies like UnitedHealth Group’s Optum will twiddle their thumbs and wait for the Feds to set standards and (good grief) enforce disclosure on AI tools, this Editor has several lovely bridges for sale. POLITICO, Becker’s

CVS Health grouping health services and multi-payer assets under CVS Healthspire. Monday’s announcement at the Forbes Healthcare Summit will roll up new $20 billion acquisitions Oak Street Health and Signify Health along with 1,100 MinuteClinics, the CVS Caremark pharmacy benefit manager (PBM), CVS Specialty, and its new Cordavis operation that works with pharmaceutical companies to bring to market  biosimilars. The rebranding, a clever melding of ‘health’ and ‘inspire’, will start this month into 2024. It’s not revealed whether the current names will be sunsetted for CVS Healthspire, or whether they will keep their established brand names. The parallels are with Evernorth (Cigna), Optum (UnitedHealth Group), and Carelon (Elevance, the former Anthem) in creating a vertically integrated healthcare company. At Investor Day, CVS Pharmacy announced a cost-plus arrangement for retail prescriptions built on the cost of the drug, a set markup, and a fee that reflects the care and value of pharmacy services–clearly in competition with Mark Cuban CostPlus.  Forbes, FierceHealthcare, CVS release, Investor Day release  

Clover Health exits the advanced value-based primary care program, ACO REACH. Clover’s exit at the end of the 2023 performance year after two years disbands their practice arrangements for CMS’ advanced original Medicare shared savings program, formerly Direct Contracting, and provision of beneficiary services after completing their required wrapups and reporting. It is part of their recent moves to become profitable, focusing on their Medicare Advantage business and Clover Assistant management. They outsourced their Medicare Advantage plan administration to UST HealthProof for a savings of $30 million and laid off 10% of staff as part of restructuring. A 2021 SPAC on Nasdaq debuting above $16 that survived investigations by the SEC and DOJ now has shares trading currently under the $1.00 minimum for listing. Clover also finally settled seven shareholder lawsuits over its non-disclosure of the DOJ investigation at the time of the SPAC. Cleaning house is all part of living to fight another day, like other ‘insurtechs’ such as Oscar Health. Clover release, FierceHealthcare  Also: Looking back at insurtechs and their ‘disruption’,  Insurtechs in the widening gyre

A Practice Fusion coda: an insider’s perspective on the pressure to ethically breach an ‘objective’ service for revenue

From both sides: an insider at Practice Fusion, then a regulator at ONC. Mentioned briefly in POLITICO Morning eHealth is a blog posting from a former ONC (Office of the National Coordinator, HHS) official, Jacob Reider, MD, about Practice Fusion. Before he was Deputy National Coordinator of Health IT, he was CMIO of Practice Fusion circa 2009-11. His blog has some interesting insights on even ten years ago, how aggressive pharmaceutical companies were in wanting to ‘bend’ (Editor’s term) clinical decision support (CDS) in the EHR to promote a drug category, and in a young, growing, and revenue-hungry company, the temptation for ‘growth’ teams to do so. Fast forward a few years, and Dr. Reider is working to write the certification requirements for EHRs and the evidence (via citations) for CDS. His conversations with the then-CEO, Ryan Howard, about the ethics of their advertising model and their rationale illustrate the conflict between ethics and revenue–as in right up to the line and looking over. While this is familiar to any media observer–after all, why buy advertising if not to change behavior?–when decisions are being guided by an EHR, the CDS shouldn’t be rigged, visibly or invisibly. Dr. Reider places the crossing of the line after Mr. Howard’s departure with a new pharma-minded team. The evidence in the CDS lies in the citations funded by–pharma and biomed companies. The inevitable result: Allscripts, now the owner, settling for $145 million with the DOJ and having ‘kickbacks’ attached to their business. Dr. Reider is now CEO of the Alliance for Better Health in Albany, NY. Docnotes: When sponsored CDS is a crime

This is hardly the first instance of the blurring of boundaries between ethics and revenue. All those paying to get their genetic history from 23andme or Ancestry.com ought to consider that they may also be signing on to have their information used by a medtech company for research. It may be stripped of PII and ‘de-identified’, but there are ways of cross-referencing some of that information. Why else would GSK own 50 percent of the company? [29 Aug 19, 31 Oct 15

Pondering the squandering redux: $28 billion gone out the HITECH window

In 2009, the US Congress enacted the HITECH Act, as part of a much broader recovery measure (ARRA or ‘the stimulus’), authorizing the Department of Health and Human Services (HHS) to spend up to $35 billion to expand health IT and create a network of interoperable EHRs. Key to this goal of interoperability and seamless sharing of patient information among healthcare providers was achieving stages of ‘meaningful use’ (MU) with these EHRs in practice, to achieve the oft-cited ‘Triple Aim‘ of improved population health, better individual care, delivered at lower per capita cost. Financial incentives through Medicaid and Medicare EHR programs were delivered through multiple stages of MU benchmarks for hospitals and practices in implementing EHRs, information exchange, e-prescribing, converting patient records, security, patient communication and access (PHRs).

Five years on, $28 billion of that $35 billion has been spent–and real progress towards interoperability remains off in the distance. This Editor has previously noted the boomlet in workarounds for patient records like Syapse and OpenNotes. Yet even the progress made with state data exchanges (e.g. New York’s SHIN-NY) has come at a high cost–an estimated $500 million, yet only 25 percent are financially stable, according to a RAND December 2014 study. (more…)

HHS draft report on health IT framework published

Another part of the 2012 FDA Safety and Innovation Act (FDASIA) clicked into place with the US Department of Health and Human Services (HHS) publishing a draft report proposing strategy and recommendations for what is rather grandly termed a “health IT framework”. Basically it defines more unified criteria, based on risk to the patient and function of what the device does, not the platform (mobile, software, etc.). It then separates products into three broad categories. Excerpted from the FDA release and the FDASIA Health IT Report:

  1.  Products with administrative health IT functions, which pose little or no risk to patient safety and as such require no additional oversight by FDA. Examples: billing software, inventory management.
  2. Products with health management health IT functions. Examples: software for health information and data management, knowledge management, EHRs, electronic access to clinical results and most clinical decision support software. This will be coordinated largely by HHS’s Office of the National Coordinator for Health IT (ONC) as part of their activities (including their current voluntary EHR certification program), but the private sector is also cited in establishing best practices.
  3. Products with medical device health IT functions, which potentially pose greater risks to patients if they do not perform as intended. Examples: computer-aided detection software, software for bedside monitor alarms and radiation treatment software. The draft report proposes that FDA continue regulating products in this last category. (Illustration on page 13 of report.)

The report also recommends the creation of a public-private entity under ONC, the Health IT Safety Center, which “would serve as a trusted convener of stakeholders and as a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.” The private sector is duly noted as a ‘stakeholder’.

The report was developed by FDA “in consultation” with ONC and, not unexpectedly, the Federal Communications Commission (FCC). Another recommendation (page 28) is the establishment of a ‘tri-Agency memorandum of understanding (MOU)’ to further determine their working relationship in this area. There’s a 90 day comment period on the 34 page report, which is perfect for weekend reading (!) How this onion will eventually be peeled, rather than quartered, remains to be seen, as does anything emanating from Foggy Bottom.  FDA release. Report. FierceMobileHealthcare.

Update 8 April: A good summary of criticism and approval of the framework to date appears in iHealthBeat from the California Health Care Foundation. The two US Senators sponsoring the PROTECT Act [TTA 28 Feb, 6 Mar] stated there is still too much regulation of low-risk technologies, and Bradley Thompson of Epstein Becker/mHealth Regulatory Coalition believes the report is weak on the issues around clinical decision support software. With praise: HIMSS, Health IT Now Coalition and ACT, which claims to represent about 5,000 mobile application developers and IT firms, but has no locatable website.

Previously in TTA: FDA finally issues proposed rule simplifying medical device classification

FDA regulating medical apps–or not? (US)

The long-drawn out drama on the FDA’s endlessly pending (July 2011) final regulations on the approval procedure of mobile health apps seems to be coming to a crescendo with next week’s US House of Representatives Energy and Commerce Committee hearings. There are missed deadlines, unanswered questions, reports due, an apparent repositioning of mobile apps as ‘health IT’, the involvement of an alphabet soup of agencies–Health and Human Services (HHS), the Federal Communications Commission (FCC) and, most importantly the Office of the National Coordinator for Health Information (ONC) under HHS, which seems to be breaking away and asserting control in the FDA vacuum. Cheering on ONC for dominance are health IT companies such as McKesson and perhaps some members of the Committee. This apparent lassitude on FDA’s part is certainly odd, as according to Mobihealthnews, the FDA has already approved 75 mobile medical apps. Brian Dolan over there has done fine work on sorting out this ‘who’s on first?‘–and why–situation in two articles, Republicans, EHR vendors want ONC to take over medical app regulation (14 Mar) and Congress asks FDA if “actual use” is factor in medical app regulation (6 Mar).

Related TTA: The mHealth road map, as drawn by the FCC and Adding another chef to the government regulation kitchen