Short takes: interesting takeaways from the Veradigm earnings call, VA cuts ~6 EHRM contracts; mergers for DispatchHealth-Medically Home, Wysa-April Health

The Veradigm earnings call following the 2022 financial release had to be…interesting, perhaps in what wasn’t said. HIStalk’s reporter took away several key points succinctly; a full reading at their site is recommended (scroll down). In brief:

  • “The financial impact of the internal control failures was $239 million in asset reduction and $46 million in fees.”
  • The company will not be current on its financial reporting until 2026
  • The core provider and life sciences businesses went wobbly
  • ScienceIO, bought in February 2024, generated no revenue. The AI/LLM acquisition was touted as being incorporated into other business lines, trimmed with jargon.

The accumulation of things that just aren’t tucked, tied, and moving forward gives the impression of uncertainty. And uncertainty is a bad place to be in a billion-dollar business. Veradigm consists of a complex mix of businesses. Yet the CEO, Tom Langan, is still ‘interim’ after 10 months which affects the leadership. Months ago, the company was for sale, yet all the interested bidders who could have well afforded Veradigm took a pass. Now they are facing a ‘standalone future’.  Right after that announcement, an activist investor intervened and is now calling the shots on board members [TTA 19 Mar, 22 Feb]. Stay tuned….

VA cutting contracts, including six EHRM sub-vendors–a wrench in the EHRM works? According to this Federal News Network report, the total number of canceled contracts, originally announced as 875 contracts, was later reduced to 585. Included in the cuts were at least six small contractors tied into the EHR Modernization (EHRM) with Cerner. While VA is ‘walking back’ the termination of some of these EHRM contractors working on essential pieces such as interoperability and HIPAA compliance, these small, generally veteran-owned companies with specialized workers have already laid off staff. What’s really telling is the statement from FNN’s source, which this Editor doubts you’d hear outside of government or a huge global company: “For every FTE in government, there’s maybe two, three, even four support resources that are assisting. The government is just there for decision-making. The groundwork, and all the other work, is being done by this contract support team. Right now, they’re just trying to do damage control.” In addition, 24 on the EHRM team either were laid off or took the buyout. Having once worked for a contracting RPM company for the Veterans Health Administration which had its contract terminated after over 10 years, this Editor can testify to 1) the devastating effect and 2) the specialized skills of people making up these support teams.  Hmmmm….

Hospital-at-home DispatchHealth and Medically Home to merge, effective mid-year. Terms of the transaction, headquarters location, and employee transitions were not disclosed. According to Healthcare Dive, Jennifer Webster, CEO for DispatchHealth, will lead the combined organization under the DispatchHealth name. Both offer same-day in home medical care, recovery services, and hospital-level care at home. DispatchHealth, headquartered in Denver, raised $403.2 million through a March 2021 Series D. Medically Home in Boston raised $197 million through a January 2022 Series D. They don’t have investors in common, unusually for mergers of late. Medically Home focuses on health systems and physician groups for serious and complex care decentralized management, while DispatchHealth base is with insurance companies, value-based entities, as well as health systems. Coverage for the combined entity is stated as nearly 40 health systems, as well as most major health plans and value-based care entities, with 2,200 employees, over half in frontline care. Release

Over in Telemental Health Land, Wysa and April Health are merging. Wysa primarily features an AI LLM chatbot for cognitive behavioral therapy, targeted to individuals and employers, while April Health partners with primary care providers for behavioral care management with live managers. The Wysa chatbot in 2022 received FDA Breakthrough Device Designation for use by patients 18 years old and older with a diagnosis of chronic musculoskeletal pain, depression and anxiety. April Health has already integrated the Wysa chatbot with its services for LifePoint Healthcare and The Newton Clinic (affiliated with MercyOne). Terms of the transaction, headquarters location, and management transitions are not disclosed. Wysa has raised about $35 million in funding, with the last round in 2023, while April Health has seed funding only. Release, Behavioral Health Business, Mobihealthnews 

Perspectives: Creating consistent standards isn’t a once and done job

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today’s contribution is from Rhod Joyce, Deputy Director of Innovation Development at NHS Transformation Directorate and previously Head of Partnerships for NHSX. As Deputy Director of Innovation Development within the NHS Transformation Directorate, Rhod works to support the ecosystem in the development, assurance, and deployment of digital tools and services at scale. Key programs include the Digital Health Partnership Award and the Digital Health Technology Assessment Criteria. He drives support for patients to access digital health apps to support the management of long-term conditions and leads the Transformation Directorate’s Partnerships team.

This is the second Perspectives contributed by Wysa, an AI-enabled therapy coach for mental and emotional wellness. It recently was granted an FDA Breakthrough Device Designation prior to premarket review. 

Interested contributors should contact Editor Donna. (Pictures and graphs are welcome)

Technology is evolving and becoming more and more commonplace in healthcare. As a result of the pandemic, more people are open to the idea of digital treatment tools, and the NHS has pledged to provide ways to ensure that digital inclusion is accelerated. On-demand healthcare, virtual reality, online treatment sessions, big data, and predictive healthcare are all improving access and outcomes. Online and digital health resources can help with prevention, self-care, shared care and shared decision-making, long-term condition management, and appropriate use of urgent and emergency care.

The challenge for commissioners comes when trying to select which tool is best. There are over 350,000 digital health apps in the market, with an average of 250 new health apps being released every day. The question then becomes, how can commissioners and clinical leads uphold safety standards, whilst putting the best tools in the hands of clinicians and patients?

Historically the NHS has worked to a number of different standards, with various contributions to the Apps Library and a digital assessment questionnaire that had evolved. From a patient-facing perspective that was very complex, but it also raised issues for commissioners who had no common standard to work towards.

In most industries such as banking or travel, there is a baseline standard that everyone adheres to and knows is a minimum – an ISO or equivalent. But healthcare has been lacking. That is why we brought together all the standards so that digital health technologies that are being considered by NHS or social care organizations should be assessed against the Digital Technology Assessment Criteria (DTAC), regardless of procurement route, by the NHS or social care organization that is buying the product.

It defines standards for clinical safety, data protection, cybersecurity, and technical assurance and interrupts and also with a view of accessibility and usability and they are set out now as the absolute baseline that digital health technologies need to meet to operate safely within health and social care. While DTAC is intended to be a ‘one size fits all’ baseline criteria in terms of safety and security, it is intended to be part of procurement, it is not intended to be the complete question set for procurements and should be supplemented with additional specifications including any policy and regulatory requirements.

Because clinical safety isn’t a once and done thing. Having a set of standards does not mean that once that box is ticked an application is fine and available to use for everyone. It’s necessary to continuously uphold clinical standards and safety logs that prove efficacy and excellence. Every interaction, assessment, and engagement will result in new information that needs to be tested against the appropriate criteria. A clinical safety risk profile is dependent on a daily update.

When we look at developing standards we need to look at a systems focus, national programs, and patient-facing criteria. These areas are three very different things but in the past have been looked at together, which has muddied the waters. DTAC applies to all types of digital health technologies, from electronic patient records to public-facing health apps.

By ensuring that the patient needs and healthcare system requirements are front and center of every development, every innovation, every interaction, we can be sure that we are delivering the right tools for truly personalized care. That commitment can’t be a one off. If we’re going to do the right thing, let’s do it repeatedly. Only with a common set of standards that are continually being addressed and revisited, can we safely operate and allow for the innovation and progression that the NHS needs to meet an increasingly complex and varied range of needs in a modern healthcare setting.

Perspectives: why digital apps need an in-house clinical safety lead

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today’s contribution is from Emma Taylor of Wysa, an AI-enabled therapy coach for mental and emotional wellness. It recently was granted an FDA Breakthrough Device Designation prior to premarket review. Ms. Taylor is Wysa’s UK child and adolescent mental health services (CAMHS) Clinical Lead and Clinical Safety Officer. She is a clinical nurse consultant specializing in children and young adult mental health, including digital mental health.

Interested contributors should contact Editor Donna. (Pictures and graphs are welcome)

One of the reasons that the NHS is so widely loved by patients and revered around the world is its commitment to doing the best thing by patients. Where many patients are is online. With over 350,000 digital health apps on the market, and an average of 250 new health apps released every day, how can we uphold safety standards while putting the best tools into the hands of clinicians, patients, employers, and employees?

Unfortunately, most tech and digital organizations don’t have in-house clinical safety officers to be accountable for clinical safety and ensure that effective clinical risk management is carried out at all stages of development and deployment.

A clinical safety officer’s role is to ensure that conclusions which are drawn are complete, objective, and based on robust evidence. Often that means pushing back and drawing an inference that perhaps a particular intervention or tool is not right for a section of the population.

Having an in-house clinical safety officer at a technology company enables them to be faster moving without compromising on integrity and safety. Having this capability in house allows a tech company to accelerate innovation in a way that is safe and aligned to both system-wide and patient needs, bearing in mind what the NHS needs to deliver the best health outcomes for the population.

As well as in-depth understanding of the rigorous evidence bases for the interventions we are delivering, we have to look at the wider context in which a tool is operating. So within mental health, it’s about seeing social media trends, and the impact that viral videos for example might be having. It’s about seeing the effects of the economy and the cost of living. Or world events and worry. It’s about looking at the language people are using and ensuring any AI language processing picks up on potential nuance and is aware of flags for concern. Most importantly, it is about working with service users to understand the contexts within which they use the technology and how they need it to work for them.

It is also essential to listen to users, and reflect and identify the experiences of people and what they want, need, and what works for them. Young people want more digital tools for mental health. That is what they are telling us. But not every technology company is doing the right thing. If they do not have clinical safety at their core, negative outcomes can occur. A clinical safety officer is constantly asking questions. What happens if this is taken out of context? What happens if something interacts? What if someone hacks? And ultimately what is the clinical risk?

Working as a clinical safety officer is an incredibly collaborative role, where it is necessary to collaborate with service users and staff across organizations such as ORCHA as well as the NHS. This means that we are able to embrace the legislative changes and be part of the conversations around what needs to be in the next round of legislation, to keep safety standards as high as possible.

Risks are always shifting and changing, and an in-house clinical safety officer means that clinical safety documents are kept up to date and implemented so that patients get the best outcomes. It’s important not to get caught up in the capabilities of technology in and of itself, and to ensure that the digital tool is safe and aligned to the real world and the system in which it operates. In the end, having a clinical safety lead is about patient safety and creating an environment that digital health care is an integral and robust part of, innovating for the best patient outcomes.