About time: digital health grows a set of ethical guidelines

February 27, 2019 | by

Is there a sense of embarrassment in the background? Fortune reports that the Stanford University Libraries are taking the lead in organizing an academic/industry group to establish ethical guidelines to govern digital health. These grew out of two meetings in July and November last year with the participation of over 30 representatives from health care, pharmaceutical, and nonprofit organizations. Proteus Digital Health, the developer of a formerly creepy sensor pill system, is prominently mentioned, but attending were representatives of Aetna CVS, Otsuka Pharmaceuticals (which works with Proteus), Kaiser Permanente, Intermountain Health, Tencent, and HSBC Holdings.

Here are the 10 Guiding Principles, which concentrate on data governance and sharing, as well as the use of the products themselves. They are expanded upon in this summary PDF:

  1. The products of digital health companies should always work in patients’ interests.
  2. Sharing digital health information should always be to improve a patient’s outcomes and those of others.
  3. “Do no harm” should apply to the use and sharing of all digital health information.
  4. Patients should never be forced to use digital health products against their wishes.
  5. Patients should be able to decide whether their information is shared, and to know how a digital health company uses information to generate revenues.
  6. Digital health information should be accurate.
  7. Digital health information should be protected with strong security tools.
  8. Security violations should be reported promptly along with what is being done to fix them.
  9. Digital health products should allow patients to be more connected to their care givers.
  10. Patients should be actively engaged in the community that is shaping digital health products.

We’ve already observed that best practices in design are putting some of these principals into action. Your Editors have long advocated, to the point of tiresomeness, that data security is not notional from the smallest device to the largest health system. Our photo at left may be vintage, but if anything the threat has both grown and expanded. 2018’s ten largest breaches affected almost 7 million US patients and disrupted their organizations’ operations. Social media is also vulnerable. Parts of the US government–Congress and the FTC through a complaint filing–are also coming down hard on Facebook for sharing personal health information with advertisers. This is PHI belonging to members of closed Facebook groups meant to support those with health and mental health conditions. (HIPAA Journal).

But here is where Stanford and the conference participants get all mushy. From their press release:

“We want this first set of ten statements to spur conversations in board rooms, classrooms and community centers around the country and ultimately be refined and adopted widely.” –Michael A. Keller, Stanford’s university librarian and vice provost for teaching and learning

So everyone gets to feel good and take home a trophy? Nowhere are there next steps, corporate statements of adoption, and so on.

Let’s keep in mind that Stanford University was the nexus of the Fraud That Was Theranos, which is discreetly not mentioned. If not a shadow hovering in the background, it should be. Perhaps there is some mea culpa, mea maxima culpa here, but this Editor will wait for more concrete signs of Action.

Is Babylon Health’s AI on par with a human diagnostician? Claim questioned in ‘The Lancet’.

November 8, 2018 | by

In July, Babylon Health released the results of their testing against the MRCGP (Member of the Royal College of General Practitioners) exam based on publicly available questions. As we reported at the time, its AI system passed the exam with a score of 81 percent. A separate test where Babylon worked with the Royal College of Physicians, Stanford University and Yale New Haven Health subjected Babylon and seven primary care physicians to 100 independently-devised symptom sets. Babylon passed with an 80 score.

Now these results are being questioned in a letter to The Lancet. The authors–a medical doctor and two medical informatics academics–argue that the methodology used was questionable. ‘Safety of patient-facing digital symptom checkers’  shows there ‘is a possibility that it [Babylon’s service] might perform significantly worse’. The symptom checking methodology was questioned for not being real world–that the data in the latter test was entered by doctors only, not by patients or other clinicians. While the authors commended Babylon for being open about their research, they felt there was an “urgent need” for improvements in evaluation methods. “Such guidelines should form the basis of a regulatory framework, as there is currently minimal regulatory oversight of these technologies.” Babylon promises a response and additional improvements, presumably from its $100 million investment in AI announced in September. DigitalHealth (UK), Mobihealthnews

The Theranos Story, ch. 49: CEO Holmes reportedly raising funds for a new company–and feeling like Joan of Arc

June 13, 2018 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Here’s the place where your money will go if you’re an investor. John Carreyrou has now compiled his reporting for the Wall Street Journal on Theranos into a new book, Bad Blood: Secrets and Lies in a Silicon Valley Startup, and it is a Must Read for this Editor and anyone interested in the nexus of Tech, Healthcare, and Hype. (The link goes to AbeBooks, a worthy marketplace for independent booksellers.)

According to Mr. Carreyrou, the founder/CEO Miss Elizabeth Holmes–still leading the company despite settling with the SEC on fraud charges, surrendering her voting control, barred from serving as a public company director or officer for 10 years, and still fighting civil lawsuits–is raising fresh funds for a new venture.

Your eyes did not fool you.

Theranos was a Dogpile of Deceit. From hacking standard Siemens blood testing machines to work with tiny samples, falsifying test results, faking up the Edison test machine, to company financials, it was one lie on the other, chronicled for our Readers in nearly 50 chapters and multiple references. 

Mr. Carreyrou was asked by former Timesman and Vanity Fair reporter Nick Bilton whether, in this unmistakable pattern, Ms. Holmes was a sociopath. Mr. Carreyrou wisely refrained from diagnosis based on a used DSM-V, being a reporter and not her psychiatrist. From Mr. Bilton’s interview podcasted on ‘Inside the Hive’:

“At the end of my book, I say that a sociopath is described as someone with no conscience. I think she absolutely has sociopathic tendencies. One of those tendencies is pathological lying. I believe this is a woman who started telling small lies soon after she dropped out of Stanford, when she founded her company, and the lies became bigger and bigger,” Carreyrou said. “I think she’s someone that got used to telling lies so often, and the lies got so much bigger, that eventually the line between the lies and reality blurred for her.”

Mr. Carreyrou, and by inference anyone who doubted her, like her CFO, and especially those who went public with criticism–well, we are the Bad Guys:

“She has shown zero sign of feeling bad, or expressing sorrow, or admitting wrongdoing, or saying sorry to the patients whose lives she endangered,” he said. He explained that in her mind, according to numerous former Theranos employees he has spoken to, Holmes believes that her entourage of employees led her astray and that the bad guy is actually John Carreyrou. “One person in particular, who left the company recently, says that she has a deeply engrained sense of martyrdom. She sees herself as sort of a Joan of Arc who is being persecuted,” he said.

Mr. Carreyrou was set upon by this ‘martyr’s’ legal pitbulls, one David Boies, until he wisely exited stage left with a bushelful of worthless stock [TTA 21 Nov 16].

(And what is it about Stanford University that fosters people like Ron Gutman, recently ousted from HealthTap over employee abuse and intimidation charges in what may be a Silicon Valley First? [TTA 3 May] Here we have someone who plays with people’s lives and health in vital blood testing. Aren’t some ethics courses long overdue?) 

Mr. Bilton makes the extremely fine point that Silicon Valley will continue to be magnetically attracted to founders equipped with a ‘reality-distortion field’ (as he termed Steve Jobs). SV will relegate Theranos to a biotech outlier. Yet as long as Silicon Valley MoneyMen like Tim Draper will back the likes of Elizabeth Holmes as long as they have a good line of (stuff), despite being embarrassingly proven not just (and only) wrong, but now perpetrating fraud, the Jobsian Myth and black turtlenecks will rise again like Dracula. (Another analogy comes to mind, but precocious children might be reading this.)

We haven’t heard the last of her.

An excellent interview by Tom Dotan of Mr. Carreyrou is podcasted on The Information’s 411 in “You’re So Vein”, which gets the award for Title of the Week (trial signup required, or listen on SoundCloud). Starting at 15:00, interesting comments on the why of Sunny Balwani and Ms. Holmes’ series of ‘marks’ including George Shultz. Also Gizmodo and Politico’s Morning eHealth newsletter.

Google ‘deep learning’ model more accurately predicts in-hospital mortality, readmissions, length of stay in seven-year study

February 14, 2018 | by

A Google/Stanford/University of California San Francisco/University of Chicago Medicine study has developed a better predictive model for in-hospital admissions using ‘deep learning’ a/k/a machine learning or AI. Using a single data structure and the FHIR standard (Fast Healthcare Interoperability Resources) for each patient’s EHR record, they used de-identified EHR derived data from over 216,000 patients hospitalized for over 24 hours from 2009 to 2016 at UCSF and UCM. Over 47bn data points were utilized.

The researchers then looked at four areas to develop predictive models for mortality, unplanned readmissions (quality of care), length of stay (resource utilization), and diagnoses (understanding of a patient’s problems). The models outperformed traditional predictive models in all cases and because they used a single data structure, are projected to be highly scalable. For instance, the accuracy of the model for mortality was achieved 24-48 hours earlier (page 11). The second part of the study concerned a neural-network attribution system where clinicians can gain transparency into the predictions. Available through Cornell University Library. Abstract. PDF.

The MarketWatch article rhapsodizes about these models and neural networks’ potential for cutting healthcare costs but also illustrates the drawbacks of large-scale machine learning and AI: what’s in the EHR including those troublesome clinical notes (the study used three additional deep neural networks to discern which bits of the clinical data within the notes were relevant), lack of uniformity in the data sets, and most patient data not being static (e.g. temperature). 

And Google will make the chips which will get you there. Google’s Tensor Processing Units (TPUs), developed for its own services like Google Assistant and Translate, as well as powering identification systems for driverless cars, can now be accessed through their own cloud computing services. Kind of like Amazon Web Services, but even more powerful. New York Times

The Theranos Story, ch. 36: Their money–and time–are running out

February 22, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]A garage sale soon for Theranos? A report in the Wall Street Journal, citing sources on a January investor call, revealed that Theranos has $200 million on hand, but zero revenue in 2015 and 2016. $200 million on hand sounds like–and is–a lot. But Theranos is, once again, oh so special. It’s less than 25 percent of their over $900 million raise. They’ve made no money in the past two years and are likely to make none in 2017 with an unapproved miniLab. Their CEO cannot run a lab by Federal action. They’ve laid off all but 200+ employees, all of whom with any shred of intelligence are job hunting. Then think of all the lawsuits: Walgreens Boots seeking to claw back its $140 million, individual and class actions on behalf of other investors, and the looming Arizona state fraud action. It’s a mere pittance when Theranos has to hire armies of attorneys who charge Billable Hours Galore and will likely lose some if not all of the lawsuits. This Editor is making an educated guess that at least one legal team is working on a bankruptcy filing. Fortune, TechCrunch, Business Insider

Forbes, like TechCrunch once a hyper-overdrive cheerleader for Ms Elizabeth Holmes and Theranos, offers up a profile of John P.A. Ioannidis, MD, DSC who holds the C.F. Rehnborg Chair in Disease at Stanford University and is director of the Stanford Prevention Research Center at the School of Medicine. Dr Ioannidis, according to the article, was the first to raise questions about Theranos’ methodology based on the obvious–that Theranos had published nothing in scientific journals. Theranos’ general counsel then reached out to suggest co-authoring an article with Ms Holmes in a major journal. Per Dr Ioannidis, it would support “the company view that FDA clearance offered the highest possible level of evidence for any diagnostics blood test technology.” They also said, “recant your existing views and writings about these misgivings.” He did neither, to his credit. The article interestingly does not explore the heat he, in as prestigious a position as he was, must have received, based on the close ties this Editor and others have noted between Stanford and Ms Holmes. Hat tip to Bill Oravecz of Stone Health Innovations

“This is the way the world ends/Not with a bang but a whimper.” T.S. Eliot puts a fine point on a Hollow Company, indeed.

See here for the 35 previous TTA chapters in this Continuing, Consistently Amazing Saga.

AI as diagnostician in ophthalmology, dermatology. Faster adoption than IBM Watson?

February 3, 2017 | by

Three recent articles from the IEEE (formally the Institute of Electronics and Electrical Engineers) Spectrum journal are significant in pointing to advances in artificial intelligence (AI) for specific medical conditions–and which may go into use faster and more cheaply than the massive machine learning/decision support program represented by IBM Watson Health.

A Chinese team developed CC-Cruiser to diagnose congenital cataracts, which affect children and cause irreversible blindness. The program developed algorithms that used a relatively narrow database of 410 images of congenital cataracts and 476 images of normal eyes. The CC-Cruiser team from Sun Yat-Sen and Xidian Universities developed algorithms to diagnose the existence of cataracts, predict the severity of the disease, and suggest treatment decisions. The program was subjected to five tests, with most of the critical ones over 90 percent accuracy versus doctor consults. There, according to researcher and ophthalmologist Haotian Lin, is the ‘rub’–that even with more information, he cannot project the system going to 100 percent accuracy. The other factor is the human one–face to face interaction. He strongly suggests that the CC-Cruiser system is a tool to complement and confirm doctor judgment, and could be used in non-specialized medical centers to diagnose and refer patients. Ophthalmologists vs. AI: It’s a Tie (Hat tip to former TTA Ireland Editor Toni Bunting)

In the diagnosis of skin cancers, a Stanford University team used GoogleNet Inception v3 to build a deep learning algorithm. This used a huge database of 130,000 lesion images from more than 2000 diseases. Inception was successful in performing on par with 21 board-certified dermatologists in differentiating certain skin lesions, for instance, keratinocyte carcinomas from benign seborrheic keratoses. The major limitations here are the human doctor’s ability to touch and feel the skin, which is key to diagnosis, and adding the context of the patient’s history. Even with this, Inception and similar systems could help to triage patients to a doctor faster. Computer Diagnoses Skin Cancers

Contrasting this with IEEE’s writeup on the slow development of IBM Watson Health’s systems, each having to be individually developed, continually refined, using massive datasets, best summarized in Dr Robert Wachter’s remark, “But in terms of a transformative technology that is changing the world, I don’t think anyone would say Watson is doing that today.” The ‘Watson May See You Someday’ article may be from mid-2015, but it’s only this week that Watson for Oncology has announced its first implementation in a regional medical center based in Jupiter, Florida. Watson for Oncology collaborates with Memorial Sloan-Kettering in NYC (MSK) (and was tested in other major academic centers). Currently it is limited to breast, lung, colorectal, cervical, ovarian and gastric cancers, with nine additional cancer types to be added this year. Mobihealthnews

What may change the world of medicine could be AI systems using smaller, specific datasets, with Watson Health for the big and complex diagnoses needing features like natural-language processing.

The Theranos Story, ch. 25: is the nadir the $400,000 harassment of whistleblower Tyler Shultz?

November 18, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]A story to make your blood…boil. Tyler Shultz is a 26 year old Stanford University grad with a biology undergraduate degree. He ‘fell in love’ with the Theranos vision of quick small blood sample testing after visiting his grandfather’s home near the campus and meeting, of all people, Elizabeth Holmes in 2011. Tyler snagged a summer internship and then a full time job during their salad and steak days (September 2013). He worked on the assay validation team, which verified the accuracy of blood tests run on Edison machines before they were deployed in the lab for use with patients.

Then it all went sideways…and down. Ms Holmes was at his grandfather’s because he is George Shultz, 95 year old former secretary of state and Fellow at the Hoover Institution based at Stanford. Mr Shultz was one of the numerous Washington alumni lending luster to the Theranos board (now advisers), such as Henry Kissinger, Sam Nunn, James Mattis and Bill Frist (the last the only one with an MD).

Tyler Shultz soon discovered, like many new graduates, that his dream job wasn’t all that it was cracked up to be. Except that it wasn’t the hours or the quality of the snacks. He discovered that the Edison machines had highly variable results when tests were rerun with the same blood sample–and they routinely discarded the outliers from the validation reports. Edison testing for a sexually-transmitted infectious disease had a claimed 95 percent sensitivity. “But when Mr. Shultz looked at the two sets of experiments from which the report was compiled, they showed sensitivities of 65% and 80%.” It only got worse when he moved to the production team, where quality control standards were routinely flunked and President Sunny Balwani pressed lab employees to run the tests anyway. Mr Shultz went directly to Ms Holmes, twice, received a nastygram from Mr Balwani for the second, and quit–but not before anonymously sending results to the New York officials who administered a proficiency-testing program and who confirmed that the results sounded like ‘PT cheating’.

The rest of the story by John Carreyou is one of corporate harassment and family estrangement: legal harassment (including private investigators) by none other than David Boies’ law firm on the pretext of ‘confidential information’; the manipulation, currying of favor and misleading of a great but aged man; and a family’s trust fractured if not broken, despite the grandson being proven right, ironically, by the same Washington agencies that his grandfather so loyally served. Mr Shultz is now working on the Cloud DX team for the VITALITI Diagnostic Android Application in the running for the Qualcomm Tricorder XPRIZE. Wall Street Journal  See here for the 24 previous TTA chapters in this Continuing Saga.

In Big Genomics, preventing unwanted hacking and identification of individuals

October 31, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/Fotolia_41683185_S-Genomics.jpg” thumb_width=”150″ /]Two Stanford University researchers, through their own ‘hacking’, are making genomics research and data base usage more secure–and shutting the door on misuse of personal genome sequences which are now available through commercial saliva testing (23andme) and even through records on family research websites.

Genomic data sets have become more accessible to researchers through a network of servers, dubbed beacons, called The Beacon Project, organized by the National Institutes of Health (NIH)-funded Global Alliance for Genomics and Health. Genomics researchers are interested in looking for a particular genetic variant in a multitude of genomic databases. Using these beacons, when a researcher finds a gene of interest, they then can apply for more complete access to the data. They can find mutations and find other researchers working on the same one.

However, the risk is that some of this data is not sufficiently de-identified, and in the process of ‘pinging’ these beacons for genetic data, someone can create an unauthorized genomic profile of that person. For instance, a ‘nefarious user’ can find the match for an individual’s genome in a heart disease beacon, then can infer that the individual — or a relative of that person — likely has heart disease. (more…)

More (much more) on tDCS brain stimulation research

August 18, 2014 | by

Prepare to be shocked! Can brain enhancing techniques via  transcranial direct-current stimulation (tDCS) be the future of performance enhancement? Will it be the future basis of recovery from some mental illnesses, stroke and other neurological diseases? It’s a hot research area, according to this Atlantic article. Researchers at DARPA, University of New Mexico, George Mason University, Stanford University, Oxford University, University of Göttingen and this Editor’s local City College of New York (CCNY) are hot on the trail. Four areas being investigated are (more…)