COVID-19: It's Now Time for Health IT Vendors to Traffick in Patient Data

In numerous posts at this blog, I've brought up the issue of hospitals and health IT sellers extracting and exchanging/selling (ostensibly) anonymized clinical data from their EMR systems.  The buyers are varied, from pharma and PBM's to academic researchers to government, and likely many others.

This practice is not new.  For example, see my Oct. 7, 2009 post "Health IT Vendors Trafficking in Patient Data?" at https://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html.

An example of EMR vendor (Cerner) data sales of "anonymous, HIPAA-compliant, EHR-derived data" for analysis. 
Cerner and EPIC are among the largest enterprise EMR sellers in the world.

Also see my November 12, 2019 post "Google’s ‘Project Nightingale’ Secretly Gathers Personal Health Data on Millions of Americans - Time to Refuse Use Of EMR's In Your Healthcare?" at https://hcrenewal.blogspot.com/2019/11/googles-project-nightingale-secretly.html.  In that post I cited an article on Google's efforts in this domain:

Google’s ‘Project Nightingale’ Secretly Gathers Personal Health Data on Millions of Americans

By Katabella Roberts

November 12, 2019

https://www.theepochtimes.com/googles-project-nightingale-secretly-gathers-personal-health-data-on-millions-of-americans_3143843.html

Google has been working with one of the largest healthcare systems in the U.S. to collect and analyze the personal health information of millions of citizens across 21 states, The Wall Street Journal reports.  The Tech giant reportedly teamed up with St. Louis-based Ascension, the largest non-profit health system in the country, last year, and the data sharing has accelerated since summer.

Code-named Nightingale, the project saw both companies collect personal data from patients, which included lab results, doctor diagnoses, and hospitalization records, as well as patient names and dates of birth.

Google said it plans to use the data to create new software that will improve patient care and suggest changes to their care.

More recently, a court review of a noncompete clause-related lawsuit "FLATIRON HEALTH, INC. v. Carson" at https://scholar.google.com/scholar_case?case=7629237467560597212, received by me via a Google alert I have active on EHR-related litigation, describes the market for medical data in more detail.

For instance:

... Flatiron's largest line of business is its real-world evidence ("RWE") service, which converts raw clinical data from patient records into a structured format so that the data can be used for research purposes.[3] After structuring the data, Flatiron aggregates the data into data sets. Flatiron generates revenue by selling data sets to biopharmaceutical companies, as well as some regulatory agencies and researchers...

... Flatiron has developed methodologies and software systems for gathering, curating, and analyzing data from electronic health records. For example, to curate data, Flatiron has formulated rules governing how Flatiron converts information conveyed by physician notes, or other raw data in a patient record, into numeric values for variables in Flatiron's data set...

... Flatiron develops and implements these methods and systems using cross-functional teams consisting of software engineers, oncologists, clinical data specialists, data entry personnel, and others. For example, Flatiron's clinical data team writes policies and procedures to govern how Flatiron's data entry personnel curate data from unstructured records, and Flatiron's research oncology team must generally sign off on those policies and procedures. Research oncologists also describe clinically relevant concepts and rules, which software engineers incorporate into Flatiron's software codes.

This is one of numerous companies who perform services like this.  (Disclaimer:  I have no connections, financial or other interests, or involvement in this company, or others like it, whatsoever.)

Some observations:

1.  Expertise for analysis of EHR-derived datasets is relatively common.

2.  Enterprise EHR systems are widespread and are capturing highly-detailed, relatively standardized data that is easily extracted, as compared to paper records.

3.  Nearly all COVID-19 patients treated in hospitals in the United States, and in other countries with widespread EHR adoption, will have detailed data stored about their demographics (including residences and recent travel), medical and social history, medication history, pre-existing medical conditions, timelines of their signs and symptoms, chronological results of labwork and imaging studies showing response (or not) to therapy, and so forth.

4.  While systems may not be "interoperable", extraction of a uniform constrained dataset from the major EHR systems is both straightforward and, apparently, done regularly for commercial and/or research purposes.

5.  Therefore, in view of the current medical and mass economic upheaval, and what seems to be increasing public impatience and distrust of the experts:

I believe and recommend that anonymized, HIPAA-compliant datasets on COVID-19 patients should be made available ASAP, for example, on an HHS website.

This would allow leveraging of widespread expertise in analysis of the data for crucial purposes including, but not limited to (just off the top of my head): a better understanding of just who is susceptible to getting severe symptoms and ARDS from COVID-19; the role of co-morbidities in outcomes; comparative effectiveness research on new and experimental treatments (such as the currently controversy-provoking hydroxychloroquine/zithromycin/zinc triad); comparison of strategies in use of mechanical ventilators; and others.

One of the motivations of widespread EHR adoption (including government incentives, and, after a few years, penalties for non-adopters) was the potential of EHRs for enabling "virtual clinical trials" to be conducted.

Up to now, EHRs have largely been an albatross to practicing physicians and nurses, who are called upon - mandated, actually - to perform a massive amounts of clerical work in data entry, in addition to clinical work. 

It's time IMHO to leverage and democratize EHR potential, not just for the benefit of high-paying data customers.

(I don't think what I describe is happening on a significant scale; I believe the data is being kept on a short leash.  I would appreciate knowing if this is not correct.)

Finally, I note that politics and the data analytics I describe don't mix well.

-- SS

Google’s ‘Project Nightingale’ Secretly Gathers Personal Health Data on Millions of Americans - Time to Refuse Use Of EMR's In Your Healthcare?

I have long written that leadership of EMR technology by the wrong people will create exceptionally adverse outcomes, clinically speaking. 

The same appears true socially.  In fact, adverse social outcomes (especially with regard to societal power structures) is one of the pillars of the domain of Social Informatics, the field that studies social impacts of new information & communication technologies (ICTs), about which I've taught and written.  (See http://www.dlib.org/dlib/january99/kling/01kling.html)

Now there's this stunning new story regarding clinical data trafficking. 

Original article is at the WSJ by Gerald F. Seib here: https://www.wsj.com/articles/google-s-secret-project-nightingale-gathers-personal-health-data-on-millions-of-americans-11573496790, but it's behind a paywall:

Google’s ‘Project Nightingale’ Secretly Gathers Personal Health Data on Millions of Americans

By Katabella Roberts

November 12, 2019

https://www.theepochtimes.com/googles-project-nightingale-secretly-gathers-personal-health-data-on-millions-of-americans_3143843.html

Google has been working with one of the largest healthcare systems in the U.S. to collect and analyze the personal health information of millions of citizens across 21 states, The Wall Street Journal reports.  The Tech giant reportedly teamed up with St. Louis-based Ascension, the largest non-profit health system in the country, last year, and the data sharing has accelerated since summer.

Code-named Nightingale, the project saw both companies collect personal data from patients, which included lab results, doctor diagnoses, and hospitalization records, as well as patient names and dates of birth.

Google said it plans to use the data to create new software that will improve patient care and suggest changes to their care.

First and foremost, the focus of this "project" is the hackneyed cybernetic miracle we've been promised for decades, the "Artificial Intelligence" that will "revolutionize" medicine. 

I view this concept as massively over-hyped and likely fraudulent, an effort to salvage the very same promises made of the entire EMR project on which has been spent hundreds of billions of dollars (more likely beyond the trillion range by now), while waiting for Godot. 

Those monies could have been better used to provide world-class healthcare for an entire population, especially considering the lack of evidence of the miracles promised.


   

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

... Patients and doctors were not notified that their data is being shared, and did not give their consent, according to the report.

One individual who was familiar with the project told the Journal that at least 150 Google employees already have access to much of the data on tens of millions of patients.

I have already written that the entire national EMR project is a mass human-subjects experiment without informed consent that can maim or kill patients in many different ways, including clinician distraction and IT error, among others.  I also note that as I've been involved in litigation support over the past decade, I've been exposed to what really happens without the filter of the press and the IT industry.  (The verdict in the last case in which I testified about Bad Health IT, for example, went to the deceased plaintiff's heirs - amounting to more than $16 million; others were in a lower but still multi-million dollar range.  Yet, you likely will never read about these in the HIT literature)

I believe this new account of clinical data trafficking is, more likely than not, true. It is a development I've fully been expecting for at least a decade now. (See my February 26, 2012 post "Proposed new Consumer Privacy Bill of Rights: Is It Too Late For Healthcare?" at https://hcrenewal.blogspot.com/2012/02/proposed-new-consumer-privacy-bill-of.html and my Oct. 7. 2009 post "Health IT Vendors Trafficking in Patient Data?" at https://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html).

This new development would represent an invitation to massive deliberate or inadvertent abuse, and is likely a massive violation of the HIPAA Privacy Act, despite claims to the contrary.

Just hours after the secret project was revealed, the two companies announced the collaboration in a press release, in which they said the joint project would see Ascension’s data moved onto Google’s Cloud platform.

The statement said the joint project aims to “optimize the health and wellness of individuals and communities and deliver a comprehensive portfolio of digital capabilities that enhance the experience of Ascension consumers, patients, and clinical providers across the continuum of care.”

More cybernetic miracles promised for the true believers, expressed in the typical IT-magic phraseology.  Plenty of profits, too.

Eduardo Conrado, Executive Vice President of Strategy and Innovations at Ascension, said: “As the healthcare environment continues to rapidly evolve, we must transform to better meet the needs and expectations of those we serve as well as our own caregivers and healthcare providers.

The "transformations" needed are to scale back the IT and the bureaucracy that burdens good clinicians and consumes massive amounts of $, and the reduction of waste on worse-than-useless Bad Health IT (http://cci.drexel.edu/faculty/ssilverstein/cases/):

Bad Health IT is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy, lacks evidentiary soundness or otherwise demonstrates suboptimal design and/or implementation. 

More corporate mumbo-jumbo:

“Doing that will require the programmatic integration of new care models delivered through the digital platforms, applications, and services that are part of the everyday experience of those we serve.”

The partnership will also explore artificial intelligence and machine learning applications to help improve clinical quality, and effectiveness, patient safety and increase consumer and provider satisfaction, according to the statement.

The data collected by today's EMRs is subject to inaccuracy for multiple reasons mentioned at this blog, including perverse incentives, clinician harassment and cognitive overload, time limitations, forced entry of some data to move further on in the record, and others.  Further,  the Bad Health IT systems used to collect and display it exposes patients to risk and injury.  "AI" will not solve these "issues."

Tariq Shaukat, President of Google Cloud, added: “Ascension is a leader at increasing patient access to care across all regions and backgrounds, particularly those in disadvantaged communities. We’re proud to partner with them on their digital transformation.

"Digital transformation" is, quite frankly, the same BS as "IT revolutionizing healthcare" that I'd heard since at least the mid-1990s (see my post "Bill, Have You Lost Your Mind?" at https://hcrenewal.blogspot.com/2006/07/bill-have-you-lost-your-mind.html where I reposted my earlier memorialization of such baldly overwrought and preposterous claims.)
 

“By working in partnership with leading healthcare systems like Ascension, we hope to transform the delivery of healthcare through the power of the cloud, data analytics, machine learning, and modern productivity tools—ultimately improving outcomes, reducing costs, and saving lives.”

More billions of dollars are to be transferred from patient care to the IT industry. 

These $ could be far better spent, IMHO, on care delivery, including to the disadvantaged and minorities, and in rethinking the current health IT morass.  (See my Jan,. 2018 post "The inevitable downgrading of burdensome, destructive EHRs back to paper & document imaging" at http://hcrenewal.blogspot.com/2018/01/the-inevitable-downgrading-of.html).

I have passed the newly-released articles on this matter to attorneys with access to the national trial lawyers' listservs, where the merits of "Project Nightingale" can be considered from the perspective of non-toothless patient's rights advocates.

FINALLY:

I believe invasive healthcare data trafficking projects like this, with potential for massive abuses, provide reasonable justification for patients to REFUSE the use of EHR's in their care.  Paper works just fine.  In fact, when the IT goes down, it's what hospitals and doctors go right back to, and the PR always claims that "patient care was not compromised."

-- SS

11/15/2019 Addendum:

There is a whistleblower (https://www.theguardian.com/commentisfree/2019/nov/14/im-the-google-whistleblower-the-medical-data-of-millions-of-americans-is-at-risk):

I didn’t decide to blow the whistle on Google’s deal, known internally as the Nightingale Project, glibly. The decision came to me slowly, creeping on me through my day-to-day work as one of about 250 people in Google and Ascension working on the project.

When I first joined Nightingale I was excited to be at the forefront of medical innovation. Google has staked its claim to be a major player in the healthcare sector, using its phenomenal artificial intelligence (AI) and machine learning tools to predict patterns of illness in ways that might some day lead to new treatments and, who knows, even cures.

Here I was working with senior management teams on both sides, Google and Ascension, creating the future. That chimed with my overall conviction that technology really does have the potential to change healthcare for the better.

But over time I grew increasingly concerned about the security and privacy aspects of the deal. It became obvious that many around me in the Nightingale team also shared those anxieties.

After a while I reached a point that I suspect is familiar to most whistleblowers, where what I was witnessing was too important for me to remain silent. Two simple questions kept hounding me: did patients know about the transfer of their data to the tech giant? Should they be informed and given a chance to opt in or out?

The answer to the first question quickly became apparent: no. The answer to the second I became increasingly convinced about: yes. Put the two together, and how could I say nothing?

-- SS

Medical Economics: Highly experienced physicians lost to medicine over bad health IT

The title of the article is actually "Physicians leaving profession over EHRs", but that title omits the real impact of the phenomenon: seasoned physicians, along with their medical expertise, judgment and experience, are lost to the pool of people entrusted to provide care thanks to poorly designed and badly implemented IT:

http://cci.drexel.edu/faculty/ssilverstein/cases/
Bad Health IT is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, lacking in evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

This is yet another article observing that the trajectory of health IT is not what the pioneers who taught me Medical Informatics intended:

Physicians leaving profession over EHRs
Medical Economics
Keith Loria
January 24, 2018
http://medicaleconomics.modernmedicine.com/medical-economics/news/physicians-leaving-profession-over-ehrs

Until recently, most doctors created their own workflows and utilized only the technology they were comfortable using. But with the implementation of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) in 2009 to stimulate the adoption of electronic health records (EHR), many physicians are finding things a bit too stressful.

In fact, a new study in Mayo Clinic Proceedings showed that physicians who are uncomfortable using EHRs are more likely to reduce hours or leave the profession.

I think it very fair to say that a majority of physicians are "uncomfortable" or at least "highly displeased" using today's EHRs.  Evidence for this assertion includes, among others, the Jan. 2015 letter from approximately 40 medical societies including AMA, American College of Physicians, American College of Surgeons, and many sub-specialty societies expressing their displeasure directly to HHS. 

See my January 28, 2015 essay "Meaningful Use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html, and the Medical Societies letter itself at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.

The research showed that while EHRs hold great promise for enhancing coordination of care and improving quality of care, in its current form and implementation, it has created a number of unintended negative consequences including reducing efficiency, increasing clerical burden and increasing the risk of burnout for physicians.

Typical of the anodyne stories in the media on bad health IT, the issue of causing increased risk and actual patient harm is omitted.

Tom Davis, MD, FAAFP, who practiced family medicine for almost 25 years in the greater St. Louis area, says the primary reason he walked away from a successful practice was the EHR, citing its use, the ethics and the burden.

“I had 3,000 patients, many I’ve known for a quarter century, a few hundred of which I delivered, all immensely valuable relationships—and all burned to the ground mostly because of the burdens of the HITECH Act,” he says. “The demands of data entry, the use of that data to direct care and my overall uncertainty about how medical data was used in aggregate all helped poison the well from which my passion for serving my patients was drawn.

In other words, his expertise, knowledge and experience, and valuable personal relationships (enhancing trust and the obtaining of the best medical histories) with his patients was sacrificed to, in essence, utopians' notions of cybernetic medicine and the wants of the financialization-of-medicine sector.

He believes that the information collected through the EHR is being used (at least in aggregate) for purposes other than the direct benefit of the individual patient so it would be unethical for him to represent otherwise to the patient. 

I had previously written on this site about the EHR companies trafficking in medical data, as in my October 7, 2009 essay "Health IT Vendors Trafficking in Patient Data?" at http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html.

In the research realm, formerly working with one of the key figures in the now-defunct Human Genome Diversity Project at Yale, I myself am personally aware of indigenous peoples refusing to take part in data collection by western scientists because they feared misuse of the data. 

I was right; the researcher proposed, and may have experimented with, using the genetic data to perfect a "forensic" identification capability essentially based on ethnic ("population") origins. 

I wrote on these issues at my September 8, 2005 essay "Academic abuses in biomedicine vs. Indigenous Peoples: The Genographic Project" at http://hcrenewal.blogspot.com/2005/09/academic-abuses-in-biomedicine-vs.html and my July 26, 2007 essay "Informed consent, exploitation and 'Developing a SNP panel for forensic identification of individuals'" at http://hcrenewal.blogspot.com/2007/07/informed-consent-and-developing-snp.html.

I thus opine Dr. Davis' concerns are quite legitimate.

As far as the burden, he notes he spent about four minutes of keyboard time for every minute of face-to-face time with a patient.

That is a huge waste of clinician time, with few proven benefits (at least outside the financial world) and known risk, e.g., ECRI Institute's yearly "Top ten technology risks in healthcare" where health IT is usually highly ranking on that list, such as at my April 2014 essay at http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html.

Ramin Javahery, MD, chief of adult and pediatric neurosurgery at Long Beach Memorial, Long Beach, California, says there are obvious financial pressures that drive people out of private practice into a larger corporate structure, but the changes in the workplace brought about by EHRs are also driving older doctors to retire rather than deal with the costs or increased work required.

“Younger physicians who are comfortable with typing, computers and the truncated patient interactions generated by EHRs do not resist its presence,” he says. “Older physicians, however, are more likely to lack those comforts. When faced with a less comfortable work environment, they choose to retire, especially since many have saved enough to be comfortable financially.”

Where do I even start?  Older doctors have a wealth of experience and hard-earned wisdom that is being sacrificed to the whims of those who think the medical robots of "Silent Running" are just on the horizon, it seems...

These robots could perform surgery.

Regarding younger (i.e., less experienced) physicians and the "truncated patient interactions generated by EHRs", those are two deleterious results of the technology.  Less experience combined with less patient interaction, plus the distractions imposed by EHR-related clerical work, create increased risk of error and patient adverse consequences.   There is little to debate on that point.

Kevin Gebke, MD, a family and sports medicine practitioner at Indiana University Health in Indianapolis, says the issue is not fear, rather it’s a matter of dramatic workflow change.

“EHRs were not designed by practicing clinicians and are not intuitive regarding the different processes that take place during a patient encounter,” he says. “Physicians must often choose between communicating with the patient and navigating within the records to enter or view relevant data. That can fragment care during a patient visit.”

His experience with EHRs is it has slowed down his workflow, causing a significant decrease in productivity.

The issue is certainly not "fear" or physicians being "Luddites", as I've pointed out in my March 11, 2012 essay "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html. 

The tension is not between doctors who "fear" technology or are Luddites, vs. the modernists.  Rather, the true tension is between clinician pragmatists and technology hyper-enthusiasts ("Ddulites") who ignore technology's clinical downsides.

“Spread this decreased capacity to see patients across the country and we then have a magnified shortage of primary care providers,” Gebke says.

That shortage is, in fact, at odds with national policy on re-populating the pool of generalists to reduce costs.

Because of this, he believes a way to keep physicians from leaving the profession over EHR issues is to get them involved in design and improvement processes.

EHR redesign can only accomplish so much.  I have reached the point where I believe the only solution to this seeming conundrum is to stop focusing on computers, and decouple physicians and nurses from cybernetic oppression.  See my August 9, 2016 essay "More on uncoupling clinicians from EHR clerical oppression" at http://hcrenewal.blogspot.com/2016/08/more-on-uncoupling-clinicians-from-ehr_91.html. 

I observed:

... In 2016, one of the largest complaints of hundreds of thousands of U.S. physicians and nurses is that they spend more time interacting with the computer than with patients.  Patients complain they cannot get eye contact from clinicians - who are tethered to a computer screen entering data - during "live" encounters.

It is my belief there is no solution to this problem other than, where appropriate and advantageous, decoupling clinicians from data input and returning to paper for data entry, that is, specialized forms as in the aforementioned post.  Data input needs to be returned to clerical personnel as in the aforementioned invasive cardiology system.

Finally, the predictable "things are getting better and utopia is just around the corner" ending to articles on the impact of bad health IT ends this Medical Economics article:
  

Things are improving

Munzoor Shaikh, director of West Monroe’s healthcare and life sciences practice in Chicago, says that while some doctors are leaving medicine due to technology learning curves, the industry is past the EHR implementation phase and has entered an EHR optimization phase where the user experience on the physician side should be improving.

“Those who have more patience than others have stuck around; hopefully this optimization phase will save some more doctors from leaving,” he says. “That said, there are some physicians who are fundamentally not built for this tech-driven world.”

The final line is nothing short of outrageous.

The truth is, there are all to many clinical information systems that are fundamentally not built for the good-practice-of-medicine-driven world.

-- SS