Live at HIMSS 2019 with OptumIQ and Harris Logic – Harlow On Healthcare

Live at #HIMSS19, I spoke with Mark Morsch, VP Technology at Optum 360. Optum is using NLP to improve clinical documentation, harness data to stratify risk, and eventually free clinicians for deeper connections with patients at the office visit. I also spoke with Hudson Harris, Harris Logic, who is working to ensure development of a common language in mental health and suicide prevention as there is in general medicine so that we can leverage the benefits of structured data in these domains.

As a bonus, check out these video postcards from #HIMSS19 (follow the link for more):

I spoke with Mark and Hudson as part of my ongoing series of fireside chats with healthcare innovation leaders – Harlow on Healthcare, on HealthcareNOW Radio. Listen to our radio station online, or ask your smart speaker (Amazon Echo or Google Home): “Find Tune In station HealthcareNOW Radio.” You can catch me live weekdays at 8:30 am, 4:30 pm and 12:30 am ET. As each new show goes live, the last one joins the archive, available via SoundCloud or your favorite podcast app (iTunesStitcheriHeartRadio). Your comments are welcome here. Join the conversation on Twitter at #HarlowOnHC.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Live at HIMSS 2019 with Lightbeam, Lumeris and StrongKey – Harlow On Healthcare

At #HIMSS19, I spoke with Jorge Miranda, EVP, Lightbeam Health Solutions and Matt Cox, CMO, Lumeris about population health and value-based care; and with Arshad Noor, CTO, StrongKey about health data security – and a different way of thinking about security. Have a listen:

As a bonus, check out these video postcards from #HIMSS19 (follow the links for more):

I spoke with Jorge, Matt and Arshad as part of my ongoing series of fireside chats with healthcare innovation leaders – Harlow on Healthcare, on HealthcareNOW Radio. Listen to our radio station online, or ask your smart speaker (Amazon Echo or Google Home): “Find Tune In station HealthcareNOW Radio.” You can catch me live weekdays at 8:30 am, 4:30 pm and 12:30 am ET. As each new show goes live, the last one joins the archive, available via SoundCloud or your favorite podcast app (iTunesStitcheriHeartRadio). Your comments are welcome here. Join the conversation on Twitter at #HarlowOnHC.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Patents in Healthcare: Who Benefits?

We have recently seen the release of a stunning allegation of patent infringement by a big pharma company. See further background courtesy of Yale law prof Amy Kapczynski here. (Even more here.) Unusually in this case, the patent holder is the US Department of Health and Human Services.

The government often licenses patents to industry (and holds quite a few of them), but no deal is in place with Gilead Sciences, maker of Truvada, an HIV drug. The medication is priced at up to $2,000 for a one-month supply, though the cost is reportedly much less than that, and the company notes that only approximately 20% of the patients who could benefit from it are receiving it now (up from 10% a couple years back). State Medicaid programs note that if they had access to the medication at lower prices, they could provide it to many more patients who need it.

The president called for eradicating HIV in the US by 2030 in his State of the Union address, but the current administration “has a mixed record” on this front (“including proposing changes to Medicare that would hit HIV-positive seniors especially hard, and firing all members of the Presidential Advisory Council on HIV/AIDS in 2018”).

Gilead and the federales are reportedly in discussions on a licensing deal but no details are public. (The government, unlike other patent holders, generally avoids enforcement litigation.)


Update 5/9/2019: HHS Secretary Azar tweeted news of a settlement. Here’s the first tweet in his thread:

Let’s explore what that means. About 100,000 US patients receive Truvada now, out of the over 1 million for whom it is an appropriate therapy. The cost in the U.S. is $24,000 a year; overseas it can be below $100. So the Secretary is accepting a $20 million per year commitment to protect $2.4 billion per year in current revenue, and much more if the drug is covered for the 90% of patients in the U.S. who aren’t getting it yet. (I’m using round numbers; figures are easily found on line.)


Widening the frame, it is worth noting that many innovations developed or discovered using federal funds (even if not at federal agencies) have been commercialized over the years by research universities, their health systems, and by companies they have spun out. Under our current system, the institution receives a licensing fee, but the federales do not — yet the government (and, indirectly, each and every one of us) ultimately foots the bill through federal and state health care programs.

One such innovation (and patent, and patent dispute) that has received much attention in recent years is CRISPR, but the issue with the patent system goes back further, even beyond the BRCA patent litigation (focused on the issue of whether something occurring in nature may be patented — it can’t), to the foundation of the now decades-long stream of patents issued to university-based researchers whose work is sponsored by federal grants.

Here’s a précis of the issue, and some possible solutions, drawn from a law review article:

By transferring ownership rights of federally funded inventions to non-government contractors and their subsequent licensees, the University and Small Business Patent Procedures Act of 1980 (Bayh-Dole Act) gives private actors unprecedented rights to intellectual property that was cultivated with public money….

Proponents argue that the Bayh-Dole Act has led to economic growth, particularly in the biotechnology industry. Critics counter that Bayh-Dole has negatively affected the practice and norms of science, created “anticommons” problems, contributed to patent hold-ups, and led to unnecessary increases in consumer prices….

Three suggestions, espoused in some form by a number of tech-transfer academics, are proffered here. First, a percentage of Bayh-Dole tech-transfer income should be sent back to federal funding agencies [to offset the “double taxation” problem of having one federal agency fund research and another federal agency pay for the end product of that research, and to otherwise allow the funder of the research to share in the economic value of the results]. Second, any researcher receiving federal funds should be allowed to use, for research purposes, all inventions developed with federal money. Finally, underutilized patents should be placed in the public domain to be monitored and exchanged through a national tech-transfer office. Implementing these three changes could go a long way to giving the taxpayer direct returns on some of the many billions of dollars spent every year on research in the United States.

(More on Bayh-Dole here and here.)

Academic medicine technology transfer offices are doing a land-office business, reaping enormous benefits under the Bayh-Dole Act. While few would argue that there should be no rewards granted to those who take on risk in commercializing inventions as well as those who actually do the inventing, the balance of risk and reward may be ripe for review.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Philips Healthcare at HIMSS19 – Population Health with Niki Buchanan and Infection Control with Brian Gross — Harlow on Healthcare

At HIMSS 2019 I spoke with two very interesting people from Philips Healthcare, Niki Buchanan and Brian Ross.

Niki Buchanan is General Manager, Population Health Management, Philips Healthcare @NikiOzBuchanan @PhilipsHealth. We discussed helping health care providers meet their patients where they are by implementing a digital health strategy. A tailored change management strategy is needed before technology can be introduced.

Niki describes Philips Healthcare’s population health management mission as being focused on extending care out of the facility and into the home – through population management and telehealth tools that balance the value of being at home, in the community, with the protections necessary to ensure security of communications including sensitive health data. If those communications indicate that values are out of bounds for a patient post-discharge, a phone call or even a home visit can be used to provide at-home care as needed.

If you think about people who are sick, who are missing work: The last thing they want to do after they’ve gotten better is actually take off work again and go back in to meet their PCP. So why not have an opportunity to connect with them in a different way? A digital way. We live in a generation of FaceTime users, Skype users. They want to have that interaction [and] even if it’s just two minutes you can cover a lot of ground by doing these types of remote patient monitoring visits.

I characterized that as the 21st century version of Doc Williams making a house call with his black bag.

Niki emphasized that these tools are not being applied just in the classic cases such as post-discharge COPD management, but also in short-term conditions such as hypertension in pregnancy, and also in emergency department visit admission avoidance strategies involving on-call specialists. New York Presbyterian, for example, has been using telemedicine in the emergency department to connect patients with specialists who can recommend on-emergent care for many patients – reducing wait times, reducing admissions, and reducing the need for on-site facilities for specialists in the ED.

Brian Ross, Business & Scientific Leader, Genomics for Infectious Disease, Philips Healthcare @PhilipsHealth. We spoke about Philips’ new epidemiology tool designed to help manage infection control … it’s the digital pump handle.

Brian explained how Philips is using clinical informatics interfaces, plus its bioinformatics stack – which can fingerprint superbugs with pathogen genomics – to identify the correlates of healthcare-acquired infections. For example: What are the points of intersection across all infections with a certain bug? Is it a single staff member? A different common data point? Using the new module, institutions can track not only each individual patient but also the pathways of care and the caregivers and the points of contact between caregivers and patients, wherever they may be within the institution.

Genotyping pathogens is much easier (and quicker, and cheaper) than genotyping humans — pathogen genomes are much smaller. Applying these tools in this realm can help improve health in a cost-effective manner.

HAIs lead to 100,000 deaths per year in the US. These illnesses add $35 billion to the US healthcare bill. And the costs associated with broad-brush efforts to limit their spread is also high. Precision analysis can pinpoint interventions: isolating one patient vs. shutting down and disinfecting every nook and cranny in a NICU.

If you had 500 infections in a hospital, the number of connections you need to investigate is over one hundred twenty five thousand to determine what’s going on with those with those particular infections. And that’s just such a big data problem. We provide the opportunity to take it off of the clinical cognitive load and put it into advanced analytics where it belongs.

Bonus: Video postcards from HIMSS19


I spoke with Niki and Brian as part of my ongoing series of fireside chats with healthcare innovation leaders – Harlow on Healthcare, on HealthcareNOW Radio. Listen to our radio station online, or ask your smart speaker (Amazon Echo or Google Home): “Find Tune In station HealthcareNOW Radio.” You can catch me live weekdays at 8:30 am, 4:30 pm and 12:30 am ET. As each new show goes live, the last one joins the archive, available via SoundCloud or your favorite podcast app (iTunesStitcheriHeartRadio). Your comments are welcome here. Join the conversation on Twitter at #HarlowOnHC.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

IBM’s Facial Recognition Database: Dangers of Hyperbole

I’m recovering from the hyperventilating hyperbole in the reportage of IBM’s labeling of a dataset of facial photographs and making it available to researchers to reduce bias in facial recognition. NBC News went with a headline that read: Facial recognition’s ‘dirty little secret’: Millions of online photos scraped without consent. That might merit a “pants on fire” rating if it were in the realm of political reporting. The photos were not “scraped.” They were licensed.

Licensed, not scraped

The NBC story linked to IBM’s discussion of its work which, in turn, identified the dataset that it used. It is the one and only YFCC100M, a set of 100 million images (and associated metadata), each of which was posted on the photo sharing site Flickr, and was licensed under a Creative Commons license by its photographer. The project is described briefly on a Yahoo! page here (Flickr has since been sold by Yahoo! to SmugMug), and in slightly greater detail here.

There are various flavors of Creative Commons licenses, and the use of the YFC110M data set is subject to its own license and set of conditions. For example, licensees of the dataset must cite a journal article that describes it, and must credit the photographers as required by the Creative Commons licenses they attached to their images.

IBM allows any subject of a photograph in the dataset to notify IBM and elect to have his or her image deleted from the dataset. However, IBM did not make public a list of individuals represented in the set of images. (There is no such list; NBC obtained a list of the Flickr user names of the photographers whose work is represented in the dataset, so that list is searchable and IBM could be asked to remove a photo taken by a certain photographer.)

(A dozen years ago, a photo with a Creative Commons license permitting commercial use, with attribution, was used by a cellular phone carrier in an ad. The subject of the photo did not approve of the use and tried to have it taken down. Her case was tossed out of federal court for jurisdictional reasons — the company was a foreign affiliate of a US company — but if it were heard the plaintiff might have prevailed on privacy rights, since her image was used for commercial purposes without compensation and the photographer could waive his rights but not hers.)

Is this a problem?

Is there a potential issue with IBM’s use of photographs of individuals (the subjects of the photos, not the photographers) who may not have consented to this use of the image when the photo was first taken? What consent, if any, should have been obtained by the photographers? Is there a right to privacy that may be asserted now even if, as is likely the case for many, if not most, of them, the photograph was taken in a public location and not for commercial purposes? Are there moral rights that IBM should honor above and beyond any legal rights?

I assume that many, if not most, of the photos in the dataset were taken in public locations (where consent of the subject is not required) or taken by photographers who knew their subjects and had their implicit or verbal consent to take the photo and post it online. Obviously, none of the subjects specifically consented to the use of their photos as part of a facial recognition training dataset. However, that is not necessarily fatal to the images being used in research. The Creative Commons license must be honored, but to the extent that IBM hews to its published condition that the use of the labeled dataset is to be limited to research, rather than commercial use, it is not clear that a privacy right of the subjects is being violated. It seems to me that the common law privacy right that might be triggered by this scenario would require a showing of damages in order to be recognized.

On the other hand, what did the photographers think they were agreeing to when they attached Creative Commons licenses to their work? What were the subjects thinking about online privacy (if they were thinking about online privacy) when they were photographed? One way of thinking about this problem is that context is everything; when the context changes, the assumptions about consent must change. (“What you tell your bank, you might not tell your doctor. What you tell your friend, you might not tell your father-in-law.” What you told Flickr ten years ago, you might not tell Flickr today.) But the internet is constantly changing. The context for the use of data is constantly changing, while a data subject’s intent regarding use of one’s data may not change. I can be delighted by one unanticipated use and dismayed by another. The question is whether there is a reliable mechanism that we can use to capture and communicate intent in a manner that transcends context. In order for intent to be honored as more than a gut feeling (cf. the famous statement on pornography by Supreme Court Justice Potter Stewart: “I know it when I see it”), we would need to revisit the legal underpinnings of the whole notion of consent or authorization or licensing the use of an image.

There oughta be a law?

Maybe. But I don’t think there is one on the books that recognizes rights that the NBC piece — and other pieces published about IBM’s labeling of the dataset — suggest have been violated. The suggestion that we have arrived in the age of Minority Report, or in the age of a surveillance economy or surveillance state, are not to be lightly dismissed. But these images were already out in the wild under Creative Commons licenses. Changing the paradigm to require advance licensing by the subject of a candid street photograph would require unwinding years of precedent and creating an unreasonable burden on photographers. The context has changed, but how can we recalibrate our intent — and our communication of our intent — after the fact? A privacy right that is a variation or an expression of the right to be forgotten might be available in some jurisdictions, but it is an after-the-fact solution, which can limit the perceived harm but not necessarily avoid it.

Susan Sontag wrote in On Photography (quoted in the NY Times article linked to above):

Photography does not simply reproduce the real, it recycles it — a key procedure of modern society. In the form of photographic images, things and events are put to new uses, assigned new meanings which go beyond the distinctions between the beautiful and the ugly, the true and false, the useful and the useless, good taste and bad.

We haven’t yet come up with a framework to change the dynamic at play here. It may be difficult to do so, and it may be too late.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

David Harlow on HIMSStv: Digital Health & the Need to Humanize Healthcare

In a brief appearance on the in-house HIMSStv programming during the HIMSS 2019 conference, I emphasized the importance of finding the right balance between digital tools and human interaction. We’ve spent a number of years chasing the ideal of digital and the scalability of digital and moving away from the human touch. We are now learning that it is absolutely necessary to humanize healthcare, to infuse solutions with empathy and to work hard to find the right blend of digital tech and humanity. Many of my clients, and many other leading healthcare innovators, are working to find that perfect balance.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting