The book of ‘Thank and Praise’ with a selection of their 1,000 messages (UK)

James McLoughlin of the UK organization Thank and Praise has reached out once again to this Editor with an update on their social thanking of the ‘unsung heroes’ in healthcare during the depths of the COVID-19 pandemic. TAP has compiled a free e-book of a selection (64 pages) of their over 1,000 messages–print and video (page 65)–posted on their thanking walls. The messages thank healthcare workers, teachers, shop workers, church staff, food deliverers, social workers, homeless outreach, and many others who helped others. The illustrations were contributed by children and young adults. The book is also being sent to the organizations mentioned in the book. Reach out to James if TAP can help your organization. Our previous coverage: TTA 10 Apr, 12 June   Press release

Nanowear’s ‘smart clothing’ in NY/NJ hospital trials to monitor patients for early-stage COVID. Is it the Year of the Sensor?

Nanowear, a NYC-based developer of cloth-based nanosensors and monitoring systems, has entered a clinical trial collaboration with two major NY/NJ-area hospital systems to test for vital signs which may be predictive of an advancing case of COVID-19. 

The goal of the investigative teams at Hackensack Meridian Health, the largest health system in north and central New Jersey with 17 hospitals plus 500 patient care sites, and Maimonides Medical Center of Brooklyn, affiliated with Northwell Health, is to determine and assess patients for early signs of the ‘cytokine storm’ in the heart and lungs which indicates inflammation within the circulatory system, often leading to severe complications and death in COVID patients. The clinical trial will monitor patients with confirmed or suspected COVID-19. The release is not specific as to whether the garment will be issued to patients monitored solely in the hospital or inclusive of patients still at home.

Nanowear’s SimpleSENSE adjustable undergarment continuously captures key physiological signs related to the onset of COVID–real-time ECG, systolic and diastolic blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature. The vital signs are then transmitted via a mobile app to a physician portal for monitoring and interpretation.  

The garment test is also significant as it is a contactless monitoring system–highly applicable to contagious diseases.

Last July, SimpleSENSE launched in a heart failure management clinical trial with Penn State Hershey Medical Center in Pennsylvania and Hackensack Meridian. The patented cloth-based nanotechnology sensors can capture up to 120 million data points per patient per day. The HF management trial was designed to validate and provide a pathway to clear its own diagnostic algorithm generated from the garment. The SimpleSENSE device and mobile platform have been submitted to FDA for Class II 510(k) clearance.  Also mHealth Intelligence.

This may be the Year of the Sensor. Human contact is out, remote monitoring is in. Earlier this week, we covered Philips integrating BioIntelliSense‘s BioSticker into its RPM systems. During 2018-2019, we profiled Doncaster UK-based MediBioSense, which uses the VitalPatch from VitalConnect. They recently announced that an enhanced VitalPatch suitable for seven-day use and body temperature sensing received CE Class IIa medical certification as well as FDA clearance. We last covered them when MBS adopted the Blue Cedar app security system in 2018, but based on their website press section, much has happened since in extending their sensor-based technologies. This Editor will try to catch up with Simon Beniston of MBS.

Can technology speed the return to office post-COVID? Is contaminated office air conditioning a COVID culprit?

Most offices in the US are still not open or only ‘essential personnel’. As this Editor noted on 19 May, a number of companies, including startups, are focusing on working with employers on return-to-work strategies. There are a raft of approaches including on-site clinics, temperature screening checkpoints, and check-in/reporting apps from Verily (Alphabet) and Fitbit’s Ready to Work. These screeners generally monitor for self-reported symptoms, but some will advise and track you to testing if you demonstrate risk, such as UnitedHealth Group and Microsoft’s ‘ProtectWell’ with a closed loop of testing recommendations that are reported to the employer. Collective Go from Collective Health goes a bit further in emphasizing up-front (molecular [PCR]) testing and continuous employee monitoring into their protocols for, apparently, every worker. OneMedical, which works with 7,000 employers, adds to their on-site management and testing additional contact tracing. FierceHealthcare

Maybe it’s in the air-conditioned air you breathe? Office building air circulation may be a culprit in the spike in Florida, Arizona, and Texas cases. The uptick in cases in Southern states where the contagion rates were initially fairly light may be due to the mostly recirculated air in office air conditioning systems. Most modern buildings don’t have windows which open. Older buildings have their own problems like mold from leaky systems and ‘soot’ (from air pollution and when people used to smoke in offices, remember when?). Newer LEED buildings are so ‘tight’ and energy efficient that air tends to be stagnant. Few buildings have good ratios of air exchange with the outside plus use HEPA filtration throughout the HVAC system. The total picture is that any virus can make its way through offices–six feet of distancing, masks, sanitization, no cafeterias, and acrylic panel separators be d****d.  (Contrast your average office building with modern commercial aircraft where about 50 percent of air is recirculated at any one time, there’s a total change about every three minutes, and HEPA filters are used! AskThePilot, a great site for all things airline)

A return-to-work readiness strategy suggested here by a Harvard Medical epidemiologist whose main area is TB spread are germicidal UV lights high in the room to catch the viruses that go up, then down. UV light for sanitization and disinfection is a technology used for several years to disinfect patient care areas (PurpleSun is one). Far-UVC, versus near-UVC, and potential uses are outlined in this Nature article from February 2018Harvard Gazette

FCC approves 70 more COVID-19 telehealth funding applications for an additional $32 million

The US Federal Communications Commission (FCC) today (1 July) approved 70 additional applications for funding telehealth during the COVID-19 pandemic. This funding covers both urban and rural providers, from large health systems to local community health centers. The funds for this thirteenth group totals $31.63 million of the $189.27 million in total funds awarded. To date, the FCC’s COVID-19 Telehealth Program, authorized by the CARES Act, has approved 514 funding applications in 46 states plus Washington, D.C. Equipment covered includes telehealth, computers, smartphones, tablets, remote patient monitoring equipment, and software.

A small sample of this group of healthcare organizations:

  •  Avera Health, South Dakota
  • Barnabas Health in NJ for remote patient monitoring equipment
  • Boston Children’s Hospital
  • Greater Philadelphia Health Action
  • Lehigh Valley Health Network in Allentown PA
  • Montefiore Medical Center in the Bronx, NY
  • Ryan Health in Manhattan
  • University of Alabama at Birmingham Hospital
  • UPMC in Harrisburg PA

FCC release. Full list of Telehealth Program recipients here.

Hackermania runs wild…all the way to the bank! Ransomware strikes Crozer-Keystone, UCSF med school, others

News to make you livid. After surviving (to date) the COVID pandemic, health systems and medical schools are being attacked by ransomware criminals. Both the small Crozer-Keystone Health System and the globally known University of California San Francisco School of Medicine have been attacked by the ever-so cutely named Netwalker (a/k/a MailTo). Yes, this criminal hacker gang isn’t outside banging pots for first responders or donating money, or even sticking to a brief truce (Emsisoft), but figuring ways to spread malware into healthcare organizations for fun and profit. 

And profitable it’s been. UCSF paid Netwalker the princely sum of $1.14 million (£910,000) in 116.4 bitcoins after an attack starting 1 June that was also (to add insult to injury) published on Netwalker’s public blog. In the timeline presented by BBC News, it was negotiated down (professionally) from $3 million; BBC also obtained some key parts of the negotiation via an anonymous tipoff, and it’s fascinating reading. Netwalker leads the victim to a dark web ‘customer service’ site where there’s a countdown to double payment or deletion of your now-encrypted data. They are also able to live chat with the victim.

UCSF was able to limit the malware encryption damage to servers within the School of Medicine (according to the BBC, literally unplugging computers; according to UCSF, isolating servers) but decided to pay the ransom to unlock the encrypted data and return data they obtained, stating in its public release “The data that was encrypted is important to some of the academic work we pursue as a university serving the public good”. They will work with the FBI on the incident and have brought on board outside expert help.

According to FierceHealthcare, Netwalker was also behind the attack on the Champaign-Urbana Public Health District (Illinois) website in March and Michigan State University’s network in May.

Paying ransom is contrary to the advice of the major world security services such as the FBI, Europol, and the UK’s National Cyber Security Centre, on the simple basis that it encourages them. It’s a true damned-if-you-do, damned-if-you-don’t situation, as Brett Callow, a threat analyst at cyber-security company Emsisoft, said to the BBC: “But why would a ruthless criminal enterprise delete data that it may be able to further monetise at a later date?” 

Crozer-Keystone to date has refused to pay ransom. On 19 June, bitcoin publication Cointelegraph published a screenshot of Netwalker’s dark web auction page of the data. Apparently it is all financial and not medical records or PHI. Crozer also isolated the intrusion and took systems offline. Crozer is a small system of four hospitals in suburban Philadelphia (Delaware County) and serves parts of the state of Delaware and western New Jersey.

Neither Crozer nor UCSF have gone public with the source of the breach, but it is known that the main lure during the pandemic has been phishing emails with COVID-19 results or news, loaded with malware downloads.

As this Editor wrote back in May 2018 on the anniversary of WannaCry, it’s not a matter of if, but when, at highly vulnerable organizations like healthcare and academia with high-value information records. Right now, the Hakbit spear-phishing ransomware connected to an Excel spreadsheet macro is targeting mid-level individuals at pharma, healthcare, and other sectors in Austria, Germany, and Switzerland, according to tech research firm Proofpoint. TechGenix

More: Becker’s 22 June on Crozer-Keystone, 29 June on UCSF, 12 largest healthcare breaches to date, 10 healthcare system incidents for June, Kroger hacking incident exposing 11,000 health records. DataBreaches.net news page.

‘Thank and Praise’ to healthcare workers continues (UK)

One of the few bright spots in the low spot of early April was learning of Thank and Praise [TTA 10 Apr]. James McLoughlin of the organization reached this Editor with an update on their social thanking of the ‘unsung heroes’ in healthcare in the continuance of the COVID-19 pandemic. They have a new television commercial out (viewable on YouTube) that highlights the ability of anyone to use their platform to thank a healthcare worker. According to Mr. McLoughlin, “So far we have received 1,000 inspiring messages of thanks which have been viewed over 500,000 on our website and social media channels.” Another feature is that those who leave messages on the Thanking Wall for healthcare workers are also invited to donate to NHS Charities Together. TAP is now also inviting companies to adopt their platform or to participate as sponsors. Find out more here. Also catch them on Facebook, Instagram, and LinkedIn

Telehealth and the response to COVID-19 in Australia, UK, and US: the paper

Published last week in the Journal of Internet Research (JMIR) is the study by Malcolm Fisk, PhD which TTA previewed last month on telehealth’s part in the two-week response, starting 12 March, in response to COVID-19 in Australia, UK, and the US. Malcolm Fisk, PhD, who our readers know as Senior Researcher at the De Montfort University in Leicester, led a group from Australia in comparing these three countries in including telehealth in their responses to the pandemic. It looks at how telehealth models were used, awareness of the role of telehealth in response, and how restrictions previously in place were dealt with. 

The study’s conclusions, briefly summarized:

  • Australia: immediately funded on 11 March with AUS $100 million (US $68 million) a “new Medicare service,” at no cost for patients, for telehealth consultations. Telehealth in Australia is well developed, particularly in rural areas, for health and social care needs. The added funding will aid in the rollout.
  • UK: at the same time, the UK was in a ‘containment’ phase with the PM’s admission that “many more families will lose loved ones before their time”. At that point, telehealth was not in the plans, but the Imperial College projections and recommendations on home quarantining and ‘social distancing’ severely affected the most vulnerable, older people. COVID wound up being quite a jolt to the NHS since telehealth is underdeveloped in most of the UK with the exception being Scotland. Clinicians to this point did not see a need, and many older people do not have access to smartphones, tablets, or the internet. Intents are good–NHSX and the Topol Report setting a framework for telehealth–but to this point telehealth rollout is limited.
  • US: 17 March could be called ‘Telehealth on Steroids’ Day, as CMS announced the ‘dramatic’ expansion of telehealth services via non HIPAA compliant platforms such as Skype and Facetime for Medicare, retroactive to 6 March. Telehealth mushroomed starting 11 March in hospitals first, reporting 15 and 20-fold increases in telehealth consults. Then CDC and the AARP got on board. The US has an uneven system, between differences in state parity reimbursement, Medicare concentrating on rural health, state Medicaid, private pay, and integrated hospital systems’ approaches. What holds telehealth back are providers and areas in the US that simply do not have the internet connectivity that telehealth consults demand.

Good reading. Telehealth in the Context of COVID-19: Changing Perspectives in Australia, the United Kingdom, and the United States Hat tip to Dr. Fisk for sending it our way!

Why ‘masking up’ isn’t such a great idea–more than a false sense of security, a possible gateway to harm

The signs and reminders to wear a mask outside the home, lest those COVID-19 germs get in (or out), are everywhere. You could be strolling on the beach, with hardly anyone in sight, or in a park with everyone more than 6′ away, and you’re made to feel guilty for wanting to breathe fresh, unimpeded air. This Editor has seen people driving cars solo–with masks on, steaming up their glasses, and restricting their vision (and apparently hearing as one hears mainly one’s breathing) for a dangerous combination in driving safety. And even in a short visit to a supermarket, a fabric mask of the type most common to us civilians can make you feel a little light-headed, as you breathe in less O2 and more of your own CO2, like breathing in and out of a paper bag–as you touch the cheese and the detergent. It all begins to appear a little less than logical, a belief shared with medical professionals with whom I’ve spoken.

Along comes the BMJ to confirm exactly these concerns–and add a few more. A team from University College London and UCL Institute of Epidemiology and Health Care responded to a BMJ editorial that advised that “surgical masks should be worn in public to prevent some transmission of covid-19 [sic], adding that we should sometimes act without definitive evidence, just in case, according to the precautionary principle”. The authors of the ‘Rapid Response’ article note that the ‘precautionary principle’ also should prevent the neglect of potentially harmful side effects of any intervention, including the wearing of masks in public.

The two acknowledged (by most) side effects are: a false sense of security that may lead some to neglect proven infection control measures like hand (and face–Ed.) washing and inappropriate use of a face mask including facial touching and infrequent washing. The writers added five others:

  • Speech is compromised, leading people to come closer simply to hear each other, and increasing contact risk
  • The face mask propels exhaled air into the eyes, leading a person to touch their eyes and possibly contaminate them
  • “Face masks make breathing more difficult. For people with COPD, face masks are in fact intolerable to wear as they worsen their breathlessness.” The rebreathed CO2 also may increase breathing frequency and deepness, thus more contaminated air exhaled in the infected, and conversely increasing their viral load.
  • If face masks are already infected, these points are amplified
  • Reduction in innate immunity that limits the spread of pathogens through the body. “If face masks determine a humid habitat where the SARS-CoV-2 can remain active due to the water vapour continuously provided by breathing and captured by the mask fabric, they determine an increase in viral load and therefore they can cause a defeat of the innate immunity and an increase in infections.”

In short, despite all the ‘stay safe’ and ‘mask up’ admonishments, there are both positive and negative effects of mask-wearing–and risks –and they certainly are not the cure-all for COVID spread. (We will, of course, see if COVID outbreaks in the next few weeks appear in the cities where demonstrations have been rampant and mask-wearing/physical distancing have been noticeably absent.–Ed. Donna)

Reflections of a TechForce19 Participant

Ever wonder what it’s like to successfully apply for, and then to deploy your program, as part of a high-stakes challenge? Reader Adrian Scaife, Business Development Manager of Alcuris Ltd., has been on an eight-week merry-go-round on hyperdrive (to mix a few metaphors). We invited him to tell us what it was like after the reports were handed in, and his impressions follow. Thank you, Adrian!

Now the Rapid Feasibility stage has been completed and outcome reports submitted, it’s a good time to sit back and take stock of the last 8 weeks.

It all started in late March when Matt Hancock asked for innovative tech companies to support vulnerable people during the Covid crisis around three themes, Optimising Staffing in Care and Volunteering Sectors, Mental Health and Remote Care. The funding available totalled £500,000 and was planned to be shared across 20 companies.

Even at the start the ambition, the scale and the pace of the initiative were very clear.

Looking back, it is apparent that the initiative has become a brand–TechForce19 – a great name, logo and its own website. The benefit to all is a set of unifying objectives, direction, urgency, and something that people and organisation can come together to support.

The sheer number of organisations involved in the initiative was breath-taking. Funding was from the Department of Health and Social Care along with the Ministry of Housing, Communities and Local Government. It was run by NHSX supported by Public Ltd., the Academic Health Science Networks including the Health Innovation Network in London and other experts from a variety of organisations.

The application process was at speed with a launch date of 24th March and application submission by noon 1st April (and that was the extended deadline!). The application form was thorough in the questions asked particularly around how you would conduct a two-week test to demonstrate that you can solve the challenge(s). We also knew it was going to be scored based on Solution feasibility, Company credibility, Impact, and Digital maturity.

The selection process was equally fast with feedback on the next stage due Friday 4th April. Friday came and went, and we feared the worst. Little did we know at the time that over 1,600 applications had been received. Just before midnight on Saturday an email was received announcing we were through to the interview stage and ours was on Monday. 60 interviews were completed over the next few days.

Just over a week later, confirmation that our proposal had been accepted, one of just 18 participants. Time to deliver on our plan. Just 10 days to plan the project in detail, provide partner training, deliver the hardware, for our partners to collect their referrals and then to deploy the Memo Connected Care Suite. Two weeks of live running. Evaluation and an outcomes report to be submitted by the 18th May.

I must give enormous praise and thanks to our partners for their commitment to deliver when all around them the pressures on their services due to Covid were unbelievable.

So now the Feasibility and Outcomes report has been submitted. We have received some terrific feedback both from families and Social Care staff. Did the project go according to plan? Well not entirely but when do they ever, especially during a national crisis.

One surprise that I shall never forget is Nasdaq, the American stock exchange, wanted to applaud digital innovators globally who were supporting the Covid fight. They promoted the work of TechForce19 on their seven storey Nasdaq Tower in Times Square, New York by highlighting each of the 18 participants.

TechForce19 is an NHSX Covid-19 response initiative, supported by PUBLIC and the AHSN Network. The views expressed in this article are those of the author and not necessarily those of NHSX or its partners.

PUBLIC’s website has profiles on the 17 other TechForce19 participants, including many names familiar to our Readers, such as Just Checking and Buddi. Our earlier article is hereHat tip to Reader Alistair Appleby.

 

 

Post-COVID back to work: for workplace screening, testing, contact tracing, there’s an app for that

If you’re looking forward to going back to the office without the children and the dog barking, and seeing people other than your family, don’t expect to go back to “The Office” Normal with kibitzing over the divider and in the kitchen/break room. Chances are the latter will be locked, and the nearest person over the divider will be six feet away. There will not only be serious physical changes to the office, starting with many fewer people there, but also apps to track your health and who you come in contact with. Your employer will be managing your potential risk for infection of yourself and others.

  • UnitedHealth Group and Microsoft’s ‘ProtectWell’ app will screen your health everyday (using Microsoft’s COVID-19 triaging Healthcare Bot and Azure. If there’s a risk of exposure or if you are exhibiting symptoms, it will direct you to a COVID-19 testing process that enables closed-loop ordering and reporting of test results directly back to employers, managed (of course) by UnitedHealth. The app will also provide guidelines and resources for a safer work environment, including physical distancing, personal hygiene, sanitation, and more. UHG and Microsoft are furnishing the app to employers at no charge. UHG has already implemented this ‘contact tracing lite’ for frontline workers and will roll out to its over 320,000 employees; Microsoft will do the same for its US-based workers. Release
  • Enterprise software company Appian released Workforce Safety and Readiness, an app to enable HR departments to plan and maintain a return to work for employees and to maintain a safer workplace. This ’employee re-entry’ app as their CEO Matt Calkins put it, is not for every company. The app will quiz employees on factors such as health data, possible virus exposures, and details about their jobs to determine when and how they should return, based on their jobs plus CDC and state guidance, both of which keep shifting; state and local guidance in particular is keeping more than one law firm quite busy. The app can then push information to workers about their new hours, area, and similar. When the employee is back to work, they can then use the app to provide feedback on crowding and lack supplies such as hand sanitizer or wipes. The app is built on a HIPAA-compliant system and originated with a self-reporting disease app. Appian is targeting larger companies with thousands of employees on a $5,000 per month subscription model. Appian page, The Protocol
  • Companies large and small have devised their own mass testing procedures for current workers and those returning, as early as the next two weeks. This next article from Protocol details several approaches, mostly around detecting the imminently ill.
  • PWC has already set up a contact tracing system for returning workers, an app that tracks contacts with the phones of others of a person who self-reports being ill. While the privacy seems pretty robust–it works on employee self-reporting and his or her AD ID on my phone, then all the other phones it had contact with over the past X days via Bluetooth. As PWC’s David Sapin of their connected solutions area put it, “But if you’re going to come back into the workplace, you need to accept having this type of app on your phone.”
  • For a really dystopian view, see this article in Bloomberg. You may be scanned thermally, have an elevator operator (back to the past!), and lots and lots of sensors monitoring your comings and goings. Facilities departments will be retrofitting for anti-microbial surfaces and plexiglass guards. Before you are allowed to return, if you are allowed to return, you may be pre-assessed for risk before you are allowed to, with bonus point for antibodies. And when you’re back in your ‘six feet office’, you’ll have many more rules governing daily desk coverings, how you interact with your colleagues, walk in the hall, go to the bathroom. Hint: buy acrylic polycarbonate manufacturer stock. ZDNet

Of course, one wonders if Unintended Consequences will be to very firmly establish a remote workforce, which is anathema to some companies, or encouraging further outsourcing of work to offshore entities.

Founder of Call9 springing back with Curve Health for nursing home telemedicine

Tim Peck MD, founder of Call9, which provided in-facility emergency care staff with telehealth capability for nursing homes, announced a new venture also targeted to nursing home/skilled nursing home (SNF) and rehabilitative health. Curve Health will provide telemedicine and health information exchange technology to SNFs and physician groups. Physicians calling on SNF patients will be able to access patient information before a telemedicine visit. According to Dr. Peck, Curve Health’s telehealth and HIE software are built on that of Call9’s. POLITICO Morning e-Health.

Call9 closed operations last July after four years and $34 million in investment. It achieved some success in New York state, covering 3,700 beds and a total of 11,000 patients treated. While they experienced measurable success–in a 200-bed SNF, they achieved a 50 percent reduction in ER admissions and a savings of $8M per year–made inroads with major payers like Anthem and Healthfirst plus expanded into community telemedicine, it ran into a funding wall all too common with this sector. While the book of business was decent and they had gone through two well-funded rounds, Call9 could not move easily into a Series C. Value-based care is a great buzzword and beloved by CMS, but it is a long payout curve, too long for many investors. More discussion on this is in our article 26 June 2019

It is a shame as New York has been the epicenter of COVID-19 nursing home fatalities, due to a foolish (and this Editor is understating) state mandate of returning recovering patients right back to their nursing homes, which could not provide the level of care or isolate them. These patients often worsened, but also infected other patients and staff. Perhaps this could have been mitigated by Call9 or similar–but likely not.

Sadly, there’s a spotlight on nursing homes, rehabs, and LTC because of this pandemic. We look forward to more news from Dr. Peck and Curve Health in this specialized and underserved area of telehealth.

The Theranos Story, ch. 63: 12 new wire fraud, conspiracy, forfeiture charges for Holmes, Balwani

The Fraud That Is Theranos manages to stay in the news, despite a global pandemic, with more fraud charges. Only a few weeks ago, things were looking up for former executives Elizabeth Holmes (left, in the Female Steve Jobs days) and ‘Sunny’ Balwani. The defense insisted that they couldn’t prepare a proper defense without breaking shelter-in-place executive orders, which built their case for delaying the original August trial date. Prosecutors are requesting 27 October; the defense 2021. In February, the nine counts of wire fraud and two counts of conspiracy were reduced by the judge, who dismissed the two conspiracy charges related to defrauding patients who did not pay directly (e.g. insurance payment) and directing doctors to misrepresent Theranos to patients. 

Now Federal prosecutors have filed 12 fresh counts of wire fraud and conspiracy against Holmes and Balwani, plus forfeiture, in the Federal US District Court, Northern District of California, in San Jose. The superseding information (link to PDF) filed on 8 May details the very public splash and claims on their capabilities made by Holmes to the media, on their website, in their Walgreens partnership, and in advertising, from 2013 to 2015. Revealed today (12 May), the expansion of charges include 12 counts of:

  • Wire fraud against Theranos investors, including conspiracy to defraud investors through false representations of their revenue, financial models, and technology, going back to 2010
  • Wire fraud against Theranos patients, through representing to doctors that the tests were accurate while knowing they were not
  • Six additional charges of wire fraud through using electronic media and electronic transfers of funds
  • Four additional charges of wire fraud in transmitting through phone and internet laboratory and blood test results, plus payments for the purchase of nearly $1.3 million in ads targeting patients and doctors for the Wellness Centers

Wrapping this up is a demand for forfeiture of proceeds (which were at least $700 million).

These felony charges carry a potential sentence of 20 years imprisonment, a $250,000 fine, three years supervised release, plus a $100 special assessment (ahem), in addition to whatever proceeds can be clawed back in what is now a worthless company.

The actual indictment needs a grand jury to be convened, which cannot happen until 1 June or later.

Additional information on The Register, BioSpace, and Fox Business.

Theranos’ fraudulent blood testing is even more relevant in this Age of COVID with reports of the proliferation and uneven performance of virus and antibody tests. Tyler Shultz, who worked at Theranos and was related to investor/advisor George Shultz, warned on 2 May that Theranos would have thrived in this hothouse. The UK alone ordered millions of kits from China, only to send them back due to poor sensitivity (ability to avoid false negatives) and specificity (ability to avoid false positives). Rapid testing kits have come under particular fire. The US opened the gates to non-FDA cleared tests in March, only to close them shut a few days ago. Only Belgium, with the highest rate of fatalities per 1,000 infections, has banned the rapid tests. Other tests are more accurate but they take more time to return results and cannot be administered at home. Many believe that they already had COVID and anxious to see if they have the antibodies (IgG) floating about in their plasma. Bloomberg

Important UK government guidance on safer workplaces during and after the COVID-19 pandemic

The UK Department for Business, Energy & Industrial Strategy has issued on Gov.UK specific advisories on workplaces and to keep workers healthy during and after the peak of this pandemic. In addition to those who’ve had to work on-site through the lockdown, as we return to business, this guidance will be helpful in assessing risk and engaging staff in changes such as physical distancing, reconfiguring offices, creating barriers, and reconfiguring work teams.

Eight work situations are identified: 

  1. Construction and outdoor work
  2. Factories, plants, and warehouses
  3. Labs and research facilities
  4. Offices and contact centres
  5. Other people’s homes
  6. Restaurants offering takeaway and delivery
  7. Shops and branches
  8. Vehicles

While not strictly digital health, this is pertinent information for us in our businesses to keep safe, particularly #3-5. Most of us won’t be working remotely forever, and quite a few of us visit homes and other offices. For our US readers, this type of guidance will also be useful–and hasn’t been seen by this Editor from the state or Federal level.

Is a COVID-19 ‘immunity passport’ next for the UK to get back to work?

The Guardian is reporting that UK ministers are in talks with Onfido, a UK company which uses facial biometrics for identity verification. An ‘immunity passport’ would combine identity verification with a medical history on whether that person has had COVID-19. The government could use antigen tests, which show current infections, or a test that detects IgM antibodies. For past infections, the test would need to detect IgG antibodies. This passport would be several months in the future.

The question is if the tests work especially for past infections and access to reliable testing. For instance, the earliest instances of COVID-19 may have occurred in the US starting in late November. Will the IgG antibody still be present? These tests are still developing and are not widespread yet, despite many companies’ claims. Both Roche in the US and Quotient in Edinburgh have new lab-based tests that apparently have superior accuracy. Roche received emergency use approval from the US Food and Drug Administration (FDA) for their test, while Quotient is claiming 99.8 accuracy for 36,000 antibody tests a day in 35 minutes.

The process that Onfido outlined works like this:

  1. Use an app to take a facial picture that you match to your government-issued id. The app matches the two to verify your identity and can also detect if the ID is fake.
  2. Get a test to determine whether you have had the coronavirus
  3. At work, you open the app at reception and take a picture of your face that generates a QR code. This is scanned by the receptionist and confirms whether you have immunity or not.
  4. If you have a match, you can enter the workplace.

Of course this discriminates against those with smartphones, and if your facial appearance has changed. Example: if your government ID was taken with a beard and you’re now clean-shaven, in this Editor’s estimation you will have a problem. Most government IDs also look like the pictures of missing appearing on milk cartons, so what your app takes could very well not match.

It’s also unknown whether the antibodies even confer immunity–and for how long.

Contact tracing in the UK: the biggest digital health test yet?

Is uncertainty over risk of data breaches and violation of data privacy in the NHS contract tracing app the real barrier to adoption? Or is the risk more complicated–the user perception of  app reliability for them to upend their life? A person might not want to have the government on record as telling them that they were “sufficiently near” a person diagnosed with coronavirus–and also believe that the app does not provide reliable information. The person receiving the alert very well may not be infected, but the risk is that they may be compelled to self-isolate and even test with repeated alerts that may or may not be accurate.

In other words, the ‘false positive’ alert syndrome. We go back to this syndrome to understand that the real test of confidence is the perception that the algorithms will, with a good deal of confidence, screen for the number and duration of contacts of other people with symptoms, and that the complex algorithms will create a correct evaluation.

With a system that relies on about 80 percent of adoption, according to a University of Oxford team, the real factor in a successful contract tracing app may be Human Behavior– how users with smartphones perceive the app as reliable in alerting them for enough risk to self-isolate, with privacy and security lesser concerns.  UKAuthority  Hat tip to reader Alistair Appleby

Telehealth and the response to COVID-19 in Australia, UK, and US: video

Malcolm Fisk, whom our Readers know as Senior Researcher at the De Montfort University in Leicester, was kind enough to forward information on a recent video interview with André Martinuzzi of the Living Innovation Project, a Europe-wide innovation group with 14 partners ‘co-creating the way we will live in 2030’.

This 17:30-minute video covers a lot of ground on the UK response to the coronavirus (the uncertainty as of mid-April), how the UK, US, and Australia have used telehealth in response, and how telehealth can ‘stick’ after the crisis, but only if we design an inclusive infrastructure. You can view the video on the Living Innovation page by clicking on ‘View Video’ on the upper right hand side, or go directly to YouTube.

There’s a brief preview in the video of Dr. Fisk’s paper (awaiting publication, co-authored with Anne Livingstone and Sabrina Pit) on ‘Telehealth in the Context of COVID-19: Changing Perspectives in Australia, the United Kingdom and the United States’. Telehealth was very rapidly put into use for diagnosis, monitoring, and home treatment of COVID patients. Restrictions were lifted and investments made in communicating the availability of telehealth. However, the infrastructure for telehealth is strained, especially in the US with a mixed, primarily private model dependent on payers or individuals paying per virtual visit. In the UK, health trusts have encouraged the use of telephonic and audio/video models. In Australia, telehealth, particularly in remote areas, is well established. TTA will keep Readers posted on the publication of this paper. A big hat tip to Malcolm Fisk.