Catchup News Roundup: UHG-Change buy final; Theranos’ Holmes sentencing delayed, ‘limited hearing’ agreed to

Note: your Editor is on the mend after returning from vacation with a nasty bug that’s laid her low for the better part of a week.

UnitedHealth Group’s Optum unit completed its acquisition of Change Healthcare, after the 10-day agreed waiting period post-decision. As planned, Change will be folded into the OptumInsight unit. The all-cash deal was either $7.8 billion or $13 billion, depending on what source you go with [TTA 20 Sept].

The Department of Justice has a generous quantity of Grade A, Extra Large Egg on its metaphorical face. The District Court decision found that the DOJ did not conclusively prove its allegations of antitrust and loss of competition in services. Statements from UHG’s competitors such as Cigna, Aetna, and Elevance (Anthem) that the acquisition would not lead them to ‘stifle innovation’ also weakened the DOJ’s case. The major conflict, ClaimsXtend, was already in progress of divestiture to TPG.

Challenging acquisitions post-closing is difficult but has happened. Readers may recall the 2019 nine-month long District Court Tunney Act review drama over the final approval of the CVS buy of Aetna, dragging on long after the buy was final and reorganization was underway. If the Tunney Act applies, and this goes to a certain Judge Richard Leon, watch out!  Optum’s release did not disclose reorganization plans or management changes. Healthcare Dive, FierceHealthcare 

Elizabeth Holmes’ sentencing delayed to allow a ‘limited hearing’ on The Mysterious Visit of Adam Rosendorff.  The ‘crafty strategy’ [TTA 16 Sept] scored a win today (3 October). Judge Edward Davila accepted the defense’s request for a limited hearing on whether there was any prosecutorial misconduct in Dr. Rosendorff’s testimony and delayed Holmes’ sentencing originally scheduled for 17 October.

In August, according to Holmes’ partner Billy Evans, in a scene lifted out of TV’s Perry Mason, Dr. Rosendorff arrived at Holmes’ home doorstep disheveled and apologetic, allegedly telling Evans that the prosecution “made things sound worse than they were.” Yet Dr. Rosendorff swore a declaration to the prosecution after the Mysterious Visit that he testified “completely, accurately and truthfully” and stood by his testimony, while expressing “compassion” for her and her family. Rosendorff’s testimony was more about the Theranos labs and how they defrauded patients based on specious PR and inflated claims, not the investor fraud of which she was convicted. 

The limited hearing has been scheduled for 17 October (the original sentencing date). Judge Davila has already stated that the hearing will not last the full day. He also offered to both the prosecution and defense options for new sentencing dates: mid-November, early December, or mid-January. How this will affect Sunny Balwani’s upcoming sentencing on 12 counts is not known. Mercury News 

Meta facing some Senate scrutiny on Meta Pixel’s health data collection–and how it’s used

A member of the Senate Homeland Security and Governmental Affairs Committee, Sen. Jon Ossoff (D-GA) has requested that Facebook’s parent, Meta, account for healthcare information that it has collected as a result of the Meta Pixel being used on leading hospitals’ websites as an ad tracker. During a hearing, Meta chief product officer Chris Cox was questioned about Meta’s having and using the data and responded, “Not to my knowledge.” According to this latest report in The Markup, Cox will follow up with a written response to the committee.

The June investigation by The Markup and STAT [TTA 17 June] investigated how these snippets of code, routinely used by developers to track website performance, could be sending to Facebook through online appointment schedulers and patient portals highly sensitive patient information. As we noted then from the article, “None of the hospitals using the Pixel have patient consent forms permitting the transmission of individual patient information, nor business associate agreements (BAAs) that permit this data’s collection.” Facebook’s defense is that it does not use this information in any identifiable way.  

Developments have moved quickly since then. According to The Markup, 28 of the 33 hospitals in the initial report have removed the Meta Pixel from their appointment schedulers or blocked it from sending patient information to Facebook. At least six of the seven health systems had also removed the pixels from their patient portals. In August, Novant Health notified patients of a code misconfiguration of their Meta Pixel tracker that may lead to unauthorized disclosure of their personal health information (PHI) [TTA 19 Aug]. North Carolina’s attorney general may investigate. Five class action lawsuits have been filed by patients, including against Novant and Medstar [TTA 23 June].

It may be that Meta may have a very hard time ‘splainin’ to Sen. Ossoff how the data flow and is used for any given account, based upon their own internal engineers’ assessments in a leaked 2021 privacy memo. But given Meta’s and the founder’s pull in the Federal government, one wonders how far all of this will go. Your Editor is not optimistic. TTA’s articles on Meta Pixel

Weekend reading: HHS Office of Information Security presentation on security risks in AI, 5G, nanomedicine, more

Earlier this month, the US Department of Health and Human Services (HHS) Office of Information Security’s Health Sector Cybersecurity Coordination Center issued a presentation/paper that discussed the cybersecurity risks for healthcare organizations in implementing artificial intelligence, 5G cellular, nanotechnologies in medicine (nanomedicine), ‘smart hospitals’, and quantum computing.

Each area is defined, benefits listed, and then security concerns.

Highlights of the cybersecurity risks:

  • AI: requires very large collections of data in order to learn; privacy and security concerns regarding personal health information (PHI); de-identified data can be re-identified (as TTA posited several years ago!)
  • 5G overlaps with IoMT (internet of medical things) tech: both devices and data need to be secured end-to-end as they connect to the network and on devices themselves; design and implementation of the software in medical devices should include a specification of cybersecurity features and validation of those features; regular updating needed
  • Nanomedicine: remote connectivity leading to ransomware and the disruption of nanotechnology devices with theoretically fatal consequences; weaponized inhalable particles as a delivery system for bioterrorism
  • Smart hospitals: an expanded attack service; considerations same as above; resilience and continuous monitoring critical
  • Quantum computing: affects all cryptographic algorithms, requiring review and updating of those that are part of  information infrastructure

Emerging Technology and the Security Implications for the Health Sector (34 slides)  Also Becker’s Health IT

ATA organizes Telehealth Awareness Week this week

The American Telemedicine Association has, without a lot of advance fanfare, put together Telehealth Awareness Week this week from Monday 18 through Saturday 24. The purpose of the week is to showcase the many ways virtual care improves access to quality healthcare services for all individuals, including members of rural and underserved communities.

Events both virtual and local are listed here including two later events:  ISfTeH’s Global Connections for Sustainable Telehealth, 6-7 November, in-person in San Jose [TTA 12 Aug], and Forefront 2022: Provider-to-Provider Telemedicine Summit, held virtually on 12 October. The Week’s 53 endorsing and founding partners are also supported by 71 Congressional Policy Champions. ATA release (PDF) 

Breaking: Judge permits UnitedHealth acquisition of Change Healthcare, denies DOJ motion (updated)

US District Court judge dismisses Department of Justice motions to prevent UHG acquisition. The decision on Monday by Judge Carl Nichols of the District of Columbia district court denies DOJ’s action to stop the deal. It also orders the planned divestment of Change’s ClaimsXten claims payment and editing software to an affiliate of TPG Capital for $2.2 billion in cash.

The DOJ and entities such as the American Hospital Association had objected to UHG’s folding Change into OptumInsight as anti-competitive. As both Optum and Change offered competing claims processing software that covers 38 of the top 40 health insurers, UHG would then solely have access to nearly all competitive payers’ information. There were other competitive issues that were dismissed in the judge’s brief opinion. (For insight, see our earlier coverage starting here.) The full opinion, originally expected in October after the bench hearing in August, is under seal due to proprietary, sensitive information and will not be released. (US v UnitedHealth Group, 22-cv-481)

DOJ’s top antitrust official, Jonathan Kanter, said they are “reviewing the opinion closely to evaluate next steps”.  DOJ’s short statement surely sounds like the DOJ will appeal. UHG and Change are moving forward “as quickly as possible”. Stay tuned.  Reuters, Healthcare Dive

Update: As reported in HISTalk from Bloomberg the all-cash deal is $7.8 billion, not the earlier reported $13 billion.

News roundup: Oracle’s modernizing Cerner’s tech, but VA hedges training with AWS; Redesign Health’s $65M raise; Kyruus buys Epion Health; Zócalo Health raises $5M seed; Cigna Evernorth adds to digital formulary

Oracle’s Q1 2023 earnings call (Motley Fool transcript here) wasn’t much of a surprise. Earnings were up 23% to $11.4 billion. Cerner contributed $1.4 billion but was partly responsible for a 34% rise in operating expenses along with their business mix of our business. The Q2 forecast is 21% to 23%. But what should not be a surprise to anyone was the rapid Oracleization of Cerner’s tech. Answering a question about what value Oracle is delivering to Cerner’s products, Larry Ellison outlined that Cerner will have its first “pretty complete” health management product out within 12 months, using the Oracle Autonomous Database that runs itself without human labor, plus an all-new application development tool called APEX, a low-code tool. Ellison claims that the APEX low-code tool has security built into the tool, thus not requiring audits, and if the application fails, it rolls over into another data center and keeps running. In contrast, using standard methods, the product would take three to four years to build. Becker’s Health IT

The Department of Veterans Affairs (VA) is relying on Amazon Web Services for training services in transitioning from VistA to Cerner Millenium. The AWS programs will train VA Office of Information Technology staff in three areas: ENCOR implementation, operating Cisco enterprise network core technologies, architecting Amazon Web Services, and Red Hat System administration. The training will cost $54,000 over a base period of about two months. Becker’s Health IT

Redesign Health’s Series C racks up $65 million from General Catalyst, CVS Health Ventures, UPMC Enterprises, TriplePoint Capital, Eden Global Partners, Euclidean Capital, Declaration Partners, and Samsung Next. Redesign is an unusual enterprise that creates startups from its own research, assembles management teams, brands, and funds them. Since 2018, they have created 40 healthcare startups. The funding will be used not for funding additional startups but to expand Redesign’s capabilities in startup creation. Some of their startups: Ever/body (cosmetic dermatology), Calibrate (weight loss, which brutally lost a quarter of the company in July), Jasper (cancer care), Vault Health (virtual diagnostics), and MedArrive (EMS dispatch). Fast Company, FierceHealthcare.

Kyruus adds patient engagement to provider search with Epion Health buy. Kyruus, headquartered in Boston, connects providers in healthcare organizations with people needing the right care, as well as for organizations to maintain provider information and data management. Epion Health, headquartered in Hoboken NJ (near NYC), developed a platform to connect patients with their providers including services such as online check-in, telehealth, integrated reminders for scheduling, and patient education. The acquisition expands Kyruus to 500 health systems and medical groups. Terms and management transitions were not disclosed. For Kyruus, which acquired patient navigation too. HealthSparq from investor Cambia Health Solutions, this helps them build out an end-to-end provider-patient platform. Kyruus release, Mobihealthnews

Startup Zócalo Health raised seed funding of $5M to launch virtual healthcare in California, Texas, and Washington. Zócalo (Spanish for plaza or town square) will offer in those states “virtual first family medicine service designed by Latinos, for Latinos”. Already operating in California, Texas and Washington will be added by end of year. Promotoras de salud will serve as health coaches to their patients. Mobihealthnews

Cigna’s health services/tech arm, Evernorth, announced that it is adding two digital health apps to its formulary: UK/US Big Health’s Sleepio for insomnia and Daylight for anxiety, Quit Genius’ alcohol use disorder and opioid use disorder programs, and HealthBeacon’s injectable medication adherence tool for inflammatory conditions. They also announced pilot programs for Jasper Health (Redesign Health, above), Zerigo Health for psoriasis and eczema, Hinge Health’s new women’s pelvic health program, and Lid Sync’s medication adherence tool. Mobihealthnews

Elizabeth Holmes’ three swings and a miss in overturning her trial verdict reveal a crafty strategy

Putting off the inevitable? Elizabeth Holmes’ legal team in the past two weeks has filed a flurry of motions in US District Court to have her verdict thrown out prior to sentencing on Monday 17 October.

  • The filing on 1 September sought to have the verdict of guilty on four counts [TTA 4 Jan] tossed with no new trial. This was denied in a preliminary ruling by Judge Edward Davila, stating that the verdict by the jury was supported by the evidence. A final ruling is pending arguments by the defense and prosecution.
  • The three filings on Tuesday 6 and Wednesday 7 September seek to have Judge Davila rule, on the basis of new evidence, for a new trial.

According to the Mercury News, the first motion on Wednesday, which states that arguments presented in the Sunny Balwani trial could have acquitted her, has little chance of being successful and in fact may be counterproductive in annoying the judge in that case–also Judge Davila. The second motion filed has a better shot, including on appeal. It centers on the “Brady rule” that requires prosecutors to disclose and turn over information that could be helpful to the defense. This was the database of patient test results that the prosecution failed to preserve. It didn’t factor in the trial, but could in the expected appeal. 

The filing on Tuesday is straight out of an episode of Perry Mason. Holmes’ partner (and father of her one-year old son) Billy Evans declared that former Theranos lab director Dr. Adam Rosendorff showed up at the door of her home in a ‘desperate and disheveled’ state. In the declaration, Evans stated that “He said he wants to help her. He said he feels guilty. He said he felt like he had done something wrong. He tried to answer the questions honestly but that the prosecutors tried to make everybody (in the company) look bad” and that prosecutors “made things sound worse than they were.” Legal experts interviewed by the Mercury News believe it’s not the remorse, but the pressure prosecutors may have put on the witness. A hearing on this would be extensive and involve both prosecution and defense. Of course, this neglects that during the trial, the defense attempted to rip apart Dr. Rosendorff’s testimony as self-serving and essentially incompetent.

Net-net, Elizabeth Holmes has a best-money-can-buy legal strategy designed to delay her serving time, if not negate it, on the four of 12 counts on which she was convicted.  Mercury News 1 Sept, Mercury News 10 Sept  Adam Rosendorff’s testimony during trial summarized in Chapters 1 and 2

News briefs, catchup edition: UnitedHealth/Change decision October?, CVS wins $8B Signify Health auction, Walgreens majority buy of CareCentrix, FTC requests more info on Amazon-One Medical

Your Editor is semi-returned from Almost Two Weeks in Another Town, with a few more days to close out September (and summer into autumn) coming up. A lot of big news broke despite the usually slow Labor Day holiday week.

UnitedHealthcare Group/Change Healthcare Federal lawsuit to be decided in October–reports. The bench trial in the US District Court in Washington DC pitted the Department of Justice and state plaintiffs against UHG’s massive $13 billion acquisition of claims and EDI/data processing giant Change. It concluded 16 August with closing arguments presented 8 September. Dealreporter via Seeking Alpha reported that UHG and Change effectively countered DOJ’s antitrust objections to the acquisition. Change Healthcare had previously sold their claims editing business to TPG Capital to ease antitrust concerns.  Whether that will be enough in the current environment with greater sensitivities around healthcare consolidation remains to be seen. If approved, Change will be folded into OptumInsight. For a deeper dive into the issues, see TTA’s earlier reporting 3 August and 23 March.

CVS Health beat out other contenders with an $8 billion cash bid for Signify Health. It was a busy Labor Day for CVS as Signify’s board met and decided that day on CVS’ cash offer of $30.50 per share in their unusual auction. Amazon, UnitedHealth Group, and little-known Option Care Health were the other bidders. Signify is a strategic boost for CVS in becoming a major player in primary care, provider enablement, and home health as we’ve summarized here from CVS’ Q2 earnings call. Signify’s capabilities in in-home health delivery and provider services were cheaper to buy than to develop. Based on the weight given to it in the CVS release, Signify’s Caravan Health and their Medicare ACOs furnishing value-based care management services to 170 providers was a significant factor in the top price paid.

New Mountain Capital and their investors own 60% of Signify and will be exiting. Signify had in July announced their own exit from the costly and problematic Episodes of Care/BPCI business acquired with Remedy Partners back in 2019. This led to most of the over 480 staff layoffs announced last month. The sale is, as usual, pending regulatory approvals and isn’t expected to close until first half 2023. Kyle Armbrester, Signify’s CEO Kyle Armbrester will continue to lead the company as part of CVS Health. Healthcare Finance, FierceHealthcare

Rival Walgreens Boots Alliance completed their acquisition of a majority share of home care coordination platform CareCentrix. Walgreens’ final payment was $330 million for 55% of the company at an $800 million valuation. As noted previously, Walgreens ‘go big or go home’ strategy in primary care kicked off in 2020 with growing investments in VillageMD, culminating in last year’s $5.2 billion for 63% of the company. The plan is to co-locate Village Medical offices with 600 Walgreens locations by 2025 [TTA 14 Oct 2021]. CVS’ recent actions can be seen as a reaction to Walgreens’ aggressive moves. Healthcare Finance

Amazon now under FTC scrutiny for One Medical acquisition. If shutting down the much-publicized Amazon Care wasn’t quite enough last month, the Federal Trade Commission (FTC) will be reviewing Amazon’s $3.9 billion buy of One Medical. This was announced in a 1Life Healthcare (parent of One Medical) 8-K filing with the Securities and Exchange Commission (SEC). Both 1Life and Amazon received requests for additional information on 2 September, above and beyond the usual required Hart-Scott-Rodino Act (HSR) reports that will be reviewed by the FTC and DOJ. Effectively it extends the HSR waiting period by 30 days after One Medical and Amazon have substantially complied with the additional information ‘second request’.

The FTC isn’t winning popularity contests with Amazon’s legal department, as the agency is reviewing their acquisition of iRobot, maker of robot vacuum cleaners. 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.

On the passing of HM Queen Elizabeth II

Editor Donna from the US and Editor Emeritus Steve join with our Readers all over the world in mourning the death of Her Majesty Queen Elizabeth II. Truly an era of history has passed with her at Balmoral. May she remain in our memories evergreen.

For the new King, may he be granted the wisdom, strength, and resolve in undertaking the many tasks in his reign for which he is now solely responsible, and may the Queen Consort be a true support to him and the nation in the many tasks she also now undertakes.

Rest in peace in concluding a job well done, Your Majesty.

 

News roundup: RPM at 79 ScionHealth hospitals, 74% of employers like virtual care despite concerns, Alma Health garners $130M, NIH’s $25M for cancer care telehealth research, Parks’ virtual Connected Health Summit 30-31 Aug

Winding up August with one last roundup…get along lil’ dogies….

Remote patient monitoring coupled with home care debuting at ScionHealth hospitals. Louisville, Kentucky-based ScionHealth, a network of 79 hospitals in 25 states, is working with Cadence Care monitoring to manage qualifying chronic care patients. Cadence’s Care in Sync RPM will first support managing hypertension, heart failure, diabetes, and chronic obstructive pulmonary disease for ambulatory patients in 18 community hospitals across 12 states, with plans to roll out to the full network. Monitoring includes blood pressure, heart rate, pulse oximeter, glucose levels, and weight. These are tracked by care teams backed up by Cadence clinicians and telehealth. ScionHealth was formed from last year’s acquisition of Kindred Healthcare by LifePoint Health to create a network of 61 long-term acute care hospitals and 18 community hospital campuses. Cadence release, HealthcareITNews

What’s not to like about virtual care? 74% of the 135 employers surveyed like the idea, but 84% had real concerns about its ability to integrate virtual and in-person services, leading to duplication of services, unnecessary care, wasteful spending, and a fragmented care experience. These concerns ranged from 57% to 69% of those surveyed. The survey by the Business Group on Health found that these large employers were very interested in virtual primary care, with 32% offering these services in 2022, projecting out to over double — 69% — doing so in three years, 2025. In terms of spending, for the first time cancer care drives more cost than musculoskeletal (MSK) conditions, attributed to pandemic-related care delays. Business Group on Health release, FierceHealthcare

A cheery note to close August is that New York City-based Alma Health has raised a Series D of $130 million in this depressed market. While its website is very much patient-facing, Alma is primarily a membership network for mental health providers to help them be in-network with payers and simplify reimbursement to thrive in private practice. Alma claims guaranteed payback for every session in two weeks and credentialing with major insurance payers in under 45 days. It also provides a practice platform for providers in all 50 states. The Series D builds upon its August 2021 Series C of $50 million, with total outside funding since 2018 of $220 million. Investors include lead on the Series D Thoma Bravo, Cigna’s venture arm, and Optum Ventures, plus lead on the Series B and C Insight Partners, lead on the Series A Tusk Venture Partners, with Primary Venture Partners and Sound Ventures. Valuation is estimated at $800 million. FierceHealthcare, Alma release

NIH’s $25 million for research into telehealth and cancer care. Four universities and institutions will lead NIH/National Cancer Institute-funded research on the effectiveness and demographic makeup of those using telehealth as part of their cancer care:

  • NYU Grossman School of Medicine: the Telehealth Research and Innovation for Veterans with Cancer (THRIVE) Telehealth Research Center will work with the Veterans Health Administration (VHA) to uncover information about the impact of demographics on care delivery
  • University of Pennsylvania: Telehealth Research Center of Excellence (Penn TRACE) takes another aspect, telehealth strategiesand their impact on shared decision-making for lung cancer care 
  • Northwestern University: Scalable Telehealth Cancer Care (STELLAR), which will study how telehealth can be used to manage and limit behaviors such as smoking and inactivity
  • Memorial Sloan-Kettering:  MATCHES (Making Telehealth Delivery of Cancer Care at Home Effective and Safe) Telehealth Research Center, focusing on telehealth’s effectiveness on treatment of breast and prostate cancer, including remote patient monitoring and telehealth. 

mHealth Intelligence, NIH release

Not too late for Parks Associates’ virtual sessions as part of their Connected Health Summit series. Two new Summit Sessions will be online Tuesday 30 and Wednesday 31 August. More information and registration here.

Aug 30 – New Opportunities in Connected Health Services: Monitoring and Home Care
• Health and Safety Monitoring
• Home Care Services

Aug 31 – Successful Strategies for Engaging Consumers
• Choice in Care: Telehealth, Kiosks, and Retail Clinics
• AI in Health: Creating Personalized Insights
• Wellness and Consumer Engagement

Part of Wednesday’s session will include “Who’s Paying for Healthcare? New Business Models”. There’s a surprising finding–74% of US internet households with children at home have used telehealth services in the past 12 months versus 32% without kids at home, and 70% are likely to use telehealth the next time they are sick. If you cannot make these sessions, their last virtual  TTA is a past supporter of the Connected Health Summit. Parks release.

Oracle in Federal court class-action lawsuit on global privacy violations; Cerner VA EHR had 498 major outage incidents, 7% of time since rollout

Oracle’s miseries multiply, both in Federal Court and with the VA. The first is taking place in the US District Court for the Northern District of California. Three plaintiffs in a class-action suit charge in a complaint filed on Friday 19 August that Oracle is running a giant ‘surveillance state’ on billions of people. From the complaint, “the regularly conducted business practices of defendant Oracle America, Inc. (“Oracle”) amount to a deliberate and purposeful surveillance of the general population via their digital and online existence. In the course of functioning as a worldwide data broker, Oracle has created a network that tracks in real-time and records indefinitely the personal information of hundreds of millions of people” and sells this information to third-parties, without consent of course.

The complaint, filed 19 August, states that Oracle’s BlueKai Data Management Platform, which includes the Oracle Data Marketplace–likely the world’s largest commercial data exchange–and to the point, the Oracle ID Graph “synchronizes the vast amounts of personal data Oracle has amassed; that is, it matches personal data that can be determined to share a common origin with other personal data.” The charge is essentially that Oracle spies on you and has set up the world’s largest surveillance database of billions of people using the billions of data points most everyone generates online over decades.

All three plaintiffs are privacy-rights advocates: Michael Katz-Lacabe of the Center for Human Rights and Privacy; Dr. Jennifer Golbeck, director of the University of Maryland’s Social Intelligence Lab; and Dr. Johnny Ryan, a Senior Fellow at the Irish Council for Civil Liberties (ICCL), and at the Open Markets Institute. 

Dr. Ryan’s organization, the ICCL, stated that “Oracle’s dossiers about people include names, home addresses, emails, purchases online and in the real world, physical movements in the real world, income, interests and political views, and a detailed account of online activity: for example, one Oracle database included a record of a German man who used a prepaid debit card to place a €10 bet on an esports betting site.”

No dates have been set for hearings or as requested, a jury trial.

In Europe, Oracle had faced similar action along with Salesforce on privacy violations under GDPR. The Privacy Collective’s case was ruled inadmissible by a judge in the Netherlands last year, but is being appealed.

If the action proceeds, this strikes at the heart not only of Oracle’s data business but also Google and any data analytics or brokerage company. Look over your shoulder…someone’s coming after you.  TechMonitor.ai

Meanwhile, back at the endless tsuris called the VA EHR implementation, Oracle Cerner got more verbal beatdowns from the VA’s Secretary of Veterans Affairs and Senate committee members. FedScoop, through a FOIA (Freedom of Information Act) request living up to its name, was able to quantify the system outages in the Cerner Millenium system between 8 Sept 2020 and 10 June 2022. Of the 640 days the system was in place, it was out or nearly out for about 45 days, or 7%, when time lost in all of the 498 incidents is calculated.

  • 428 incomplete functionality incidents (930 hours of the system partially not working)
  • 49 degradations (103 hours of degraded performance)
  •  24 outage incidents (40 hours of complete down time) 

Where responsible parties could be identified, Oracle Cerner was responsible for about two-thirds of the incidents. Interestingly, the remainder were attributed to the VA. As to root causes, the VA could not identify them in about 50% of the cases. There’s some squirreliness in VA’s internal reporting on multi-day outages, which are more serious because the longer the outage, the more damage and the harder it is to pin down a cause.

Secretary of Veterans Affairs Denis McDonough said to FedScoop: “The bottom line is that my confidence in the EHR is badly shaken.” which has to count as an understatement significant enough to hold off further implementation until 2023. House Veterans Affairs Subcommittee on Technology Modernizing Ranking Member Mike Bost, R-Ill., said: “The number of incidents listed in this disclosure is alarming. Some part of the Cerner system has been down more often than not for nearly two years.” 

The Showboat of Misery keeps Rollin’ Down the River: the 4 Aug outage, the Senate hearing with Oracle’s Mike Sicilia, the infamous ‘unknown queue’ 21 July and 21 June

Week-end news roundup: Fitbit revives with 3 new watches, Sena Health hospital-at-home, SteadyMD surveys telehealth clinicians, 9.4% fewer adult dental visits in England, save the date for ATA 2023

Fitbit’s three new wearables–will they revive the brand? Fitbit, now owned by Google, announced the debut of two new smartwatches and one fitness tracker, available now for preorder and shipping in September. Will buyers find them more attractive than their predecessors? From left to right:

Fitbit Inspire 3 upgrades from the predecessor with a color display and similar $99.95 price. Monitors for irregular heartbeat, reminders to move, wakey-wakey alarm, apps, and more.

Fitbit Versa 4 is a thin, light fitness smartwatch with sleep, SpO2 monitoring, GPS, irregular heartbeat, stress, pay hands free, Amazon Alexa, and connects to your smartphone. Four colors, will set you back $229.95.

Fitbit Sense 2 is chunkier with more information and tracking on health and stress than Versa 4 for a higher price at $299.95.

Readers can weigh in on whether these will be attractive, as the Fitbit brand has, over the past two years, almost vanished from the fitness smartwatch consciousness. GearPatrol, Mobihealthnews

New entrant in the developing hospital-to-home service provision area Sena Health is partnering with southern New Jersey’s Salem Medical Center to deliver Salem’s hospital-to-home program. Sena’s capabilities with Salem include up to 23 hospital-level services at home and 24/7 care coordinators. To qualify, patients must have been seen in the ER and evaluated on certain criteria. When cared for at home, they receive two in-person nursing visits daily and can connect with a dedicated clinical team if needed. Hospital-to-home is being trialed all over the country and is considered to be ‘hot’, but at this point is not all that widespread. HealthcareITNews

SteadyMD conducted a survey among a group of potential workers for their telehealth care team, among 1,700 clinicians: doctors (35%), nurse practitioners (52%), and therapists (12%). Some interesting findings such as:

  • Experienced (10 years +) doctors and therapists are most interested in telehealth practice, with nurse-practitioners (NPs) less so
  • Flexible schedules and working from home are the main attractions
  • Night shifts are attractive to 86% of therapists. Doctors and therapists average about 60%. But the latter two are far more interested in weekend work–not the therapists.
  • Telehealth as a full time delivery of care goes between 50 and 69% for each. Clinicians want more hours if the arrangement is part-time.

SteadyMD is a telehealth infrastructure provider that works with healthcare organizations, labs and diagnostics companies in 50 US states.

Something that can’t be delivered by telehealth except for diagnosis is your annual dental visit and treatments, and it’s down 9.5% in England, based on a report published by NHS Digital. The tracking of NHS adult dental visits covers the 24 months prior to June 2022 compared to the 24 months prior to June 2021. When compared to the 24 months up to June 2019, the reduction is 25.3%. Since dental practices closed except for emergency care due to Covid in March of 2020, there is an overlap in the numbers. They do indicate that dental treatments have not recovered in volume from before the pandemic. One good sign is that child dental treatment has strongly rebounded, up 42.1% in the 12 months prior to June 2022 versus up to June 2021, but still down over 20% compared to the 12 months prior to June 2019. Regional data is included in the NHS Digital report (link above).

The American Telemedicine Association announced its 2023 ATA annual conference will be in San Antonio, 5-7 March 2023. More information on “From Now What? to How To! The Vision and Realities of Telehealth Adoption” already is up on their website here.

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.

Breaking: Amazon Care shutting down after three years–what’s next? (updated)

Amazon Care to cease operations after 31 December. Amazon Health Services is throwing in the towel on its primary care service for enterprise customers, after failing to make much headway with its mix of virtual care, in-home, and telehealth services. An internal email from Neil Lindsay, Amazon Health Services senior vice president, sent today (24 Aug) to employees but leaked to the press, stated that “This decision wasn’t made lightly and only became clear after many months of careful consideration. Although our enrolled members have loved many aspects of Amazon Care, it is not a complete enough offering for the large enterprise customers we have been targeting, and wasn’t going to work long-term.”

Employees who have been part of Amazon Care may have the opportunity to transfer to other parts of Health Services, according to the memo, or will be ‘supported’ in finding other roles within or outside the company. The total number of employees was not disclosed, but this Editor expects layoffs to be announced by the fall as Amazon Care winds down.

Amazon has been moving in a different direction with enterprises for some months. Reportedly the decision was made to ditch Amazon Care prior to agreeing to acquire One Medical, which was announced late in July. However, recently revealed negotiations actually started last February, with One Medical pitting Amazon against CVS until CVS dropped its bid effort [TTA 19 August]. 

As this Editor noted last month with the One Medical acquisition, “…for this Editor it is clear that Amazon with One Medical is buying itself into in-person and virtual primary care for the employer market, where it had limited success with its present largely virtual offering, and entreé with commercial plans and MA.” With One Medical, they will be acquiring an operation with 790,000 patients (including 40,000 at-risk, presumably Iora’s), 8,000 company clients, 125 physical offices in 21 US metros (including projected), and an established telehealth/telemedicine protocol. In other words, a ready-made provider and enterprise base to build on and sell into, for instance Amazon products like Pharmacy and PillPack.

Not addressed is what will be done, if anything, to transition current employer agreements for Amazon Care to One Medical.

It’s now a matter of whether HHS, DOJ, and FTC will agree to the buy or ask for additional divestitures. One conflict–Amazon Care–has just been removed. And this may clear the deck for other acquisitions, such as Signify Health [TTA 24 Aug], if Amazon wins the auction against CVS, UnitedHealth Group, and Option Care Health, though for a newcomer to healthcare Signify may very well be A Bridge Too Far.

What’s in play?

  • One Medical’s Iora Health and its high needs/high costs Medicare patient base. This has very much been held in the background, leading this Editor to think it will be sold to another health plan.
  • The status of the previous agreement with Crossover Health for 115,000 Amazon employees and dependents, delivered through their employer-based onsite clinics in 11 states in addition to concierge care [TTA 17 May]
  • Another previous agreement with Ginger for telemental health, only announced last week.

Amazon was touting Amazon Care as recently as earlier this year to shareholders. They had acquired employers outside Amazon such as Hilton, but not quickly enough. Expansion talk and the usual touting within the industry weren’t happening. There was an ‘air of mystery’ about what Amazon Care was doing, going back to the beginning.

Perhaps a major ‘tell’ was that Kristen Helton, general manager in charge of Amazon Care, was reported two weeks ago by Bloomberg News to be taking an “extended break to spend the summer with her family.” She had been in the GM position for three years after joining Amazon in 2015.

Count Amazon Care as one expensive learning course in the insanely costly University of Healthcare Delivery. This won’t be the first lesson, but Amazon can afford the tuition.

Geek Wire, FierceHealthcare

Babylon Health exits last NHS hospital contract as a ‘distraction’, looks to US market for growth

Babylon Health’s rollercoaster ride continues. Today’s news was that their last of three NHS Trust contracts, with Royal Wolverhampton NHS Trust (RWT), was ended by Babylon two years into a ten-year contract. This follows the end of two other contracts that drew a fair amount of controversy (see our index here)–the 2020 one-year Royal Berkshire NHS Foundation Trust with an accident and emergency triage app that was discontinued by Babylon, and with University Hospitals Birmingham NHS Foundation Trust (UHB) for a virtual A&E app that was ended in July.

In the UK, Babylon will continue its GP At Hand service that took over a GP office in Fulham, London in 2016. It now currently covers about 155,000 patients. It will also maintain the AI-based chatbot used for triaging patients. GP At Hand is not profitable. GP practices work on a flat fee per patient that averages £155 ($183) per patient per year.

Babylon and RWT contracted in 2021 for a digital-first primary care service that would cover 55,000 patients, with a patient portal that would enable them to view their health records and view appointments. The app would also monitor conditions and like the AI chatbot, help to diagnose illness and actions. Babylon is ending the ten-year contract after two, which would make it 2023.

From the bubbly Digital Enthusiasm of former Health Minister Matt Hancock (left) in 2018 to the storm around @DrMurphy11, a GP who raised performance issues with the Babylon chatbot that escalated to BBC Two’s Newsnight in February 2020, founder and CEO Ali Parsa is now in an unenviable position in two countries. He 1) has semi-exited the UK market, 2) ruthlessly cut costs to the bone because the stock is down 90%, and 3) shifted to the far larger but unforgiving market of the US. The bright spot here is that US patients covered have already topped 6 years of effort in the UK. Parsa has now moved to the US.

Parsa noted in a recent results call [Seeking Alpha-Ed.] with analysts. “Those two or three small NHS contracts that you refer to—and those are not our significant primary-care contracts— those are marginal contracts for us, more in that category of contracts where we could not see a significant contribution to our profit margin,” he said. “And they also had a rather small contribution to our revenue. And therefore we saw them as a distraction and terminated those contracts.”

This Editor has previously noted Babylon’s layoffs/redundancies of at least 100 staff to save $100 million by Q3, which we are now in. Expansion in the US has to take place with static staff to make goal. And as to the US being unforgiving: VCs are snapping their capacious purses shut, Mr. Market’s gone into rehab, and inflation is shrinking healthcare budgets from providers to payers to self-insured companies. The Big Kahunas with Big Bucks–CVS Health, Allscripts, UnitedHealth Group, Amazon, Walgreens, Walmart–and out-of-left-field players like Option Care Health bidding on Signify Health, are snapping up, as we’ve earlier put it, “healthy health tech companies at the right (discounted) price that fill in their tech gaps”. And making life difficult for single players like Babylon Health. Wired. And a snappy hat tip to HISTalk.