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

September 20, 2022 | by

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

September 20, 2022 | by

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

September 20, 2022 | by

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)

September 20, 2022 | by

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

September 20, 2022 | by

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

September 16, 2022 | by

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

September 15, 2022 | by

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

September 9, 2022 | by

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

September 8, 2022 | by

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.