Continuing my practice of “flipping” an event — posting what I hope to get across in advance in order to jump start the conversation — here is a preview for a panel set to take place on Oct. 23. My co-panelists (Iya Khalil, Deborah Kilpatrick, and Don Rucker) and I will talk about data as an engine of disruption in health care at the Milken Institute’s Future of Health Summit 2018.
My essential message is that patients and caregivers should be as much a part of the disruption conversation as any other stakeholder.
All of us, no matter what role we play in the health care ecosystem, should focus on giving individuals access to their own data and work up from there. And when I say data I mean everything: medical records, device data (such as pacemakers and continuous glucose monitors), and their personal tracking of symptoms (what else? Please share your thoughts in the comments below). We should also encourage the marketplace for apps and other ways to help people make sense of their data.
The Blue Button initiative, which started in the Obama Administration and continues today, is an example of what people in the industry call “consumer-directed exchange” (CDEx) of health data. As I wrote in my recent post about how consumer access is Blue Button’s North Star: “We had to start somewhere and we started with patients.” Anil Sethi, CEO of Ciitizen (a company I’m advising) recently wrote: “Make the data available to patients and it becomes instantly portable.” If you want to learn more, the CARIN Alliance explains the CDEx model well.
Another positive development: Nationwide, 30 31 million patients now have online access to the notes* that their clinicians write in their medical records (according to OpenNotes). Research shows that an increase in transparency is associated with an increase in shared decision-making — that is, the more access patients have to data about their health condition, the more likely they are to engage in treatment and problem-solving (that is positive disruption in my view).
More broadly, both the Obama and Trump Administration’s health officials are working on “seamless exchange” of health data among stakeholders, including individuals. As Centers for Medicare and Medicaid Services Administrator Seema Verma recently wrote on Twitter: “Patients deserve electronic access to their health data, doctors should be able to seamlessly exchange data between EHRs, & EHRs should allow third-party applications to leverage that data in innovative ways for the benefit of all.”
But in reality, many people have not been able to gather their own medical records. A clutch of recent articles has documented their struggles.
If you haven’t read it yet, click through on “Paper Trails: Living and Dying with Fragmented Medical Records.” As Lisa Bari, Health IT Lead of the Seamless Care Models Group at Center for Medicare & Medicaid Innovation, wrote on Twitter:
“I’ve already shared this excellent article a few times, but I need to get a rant off my chest really quickly. This fragmentation, lack of interoperability HARMS patients. Every single day. Even if you want to believe that providers aren’t actively trying to harm patients, what happens when you go to see a specialist, get tests that would result in the need for an immediate intervention, but there’s no follow up? The data lives in a silo, no one is alerted. This is a trivial issue, based on the technology. The simplest thing, barring a national [health information exchange], would just be for the specialist to send a direct message to the [primary care physician (PCP)] with the information, as well as the patient. But it rarely, if ever, happens. Of course the specialist is on EHR 1, the PCP on EHR 2 (instance 1), the urgent care clinic on EHR 2 (instance 2), and none of these systems are exchanging data. This experience x 1000000 every single day.”
Another article’s authors deployed a “mystery shopper” technique to test how easy or hard it is to get a complete medical record for an individual. See:
Assessment of US Hospital Compliance With Regulations for Patients’ Requests for Medical Records, by Carolyn T. Lye, BA; Howard P. Forman, MD, MBA; Ruiyi Gao, BS; Jodi G. Daniel, JD, MPH; Allen L. Hsiao, MD; Marilyn K. Mann, JD; Dave deBronkart, BS Hugo O. Campos; Harlan M. Krumholz, MD, SM (JAMA, Oct. 5, 2018).
A quote from the Key Points:
Question Are US hospitals compliant with federal and state regulations in their medical records request processes?
Findings This cross-sectional study of 83 US hospitals revealed that there was noncompliance with federal regulations for formats of release and state regulations for request processing times. In addition, there was discordance between information provided on medical records release authorization forms and that obtained directly from medical records departments regarding the medical records request processes.
Meaning Discrepancies in information provided to patients regarding medical records request processes and noncompliance with regulations appear to indicate the need for stricter enforcement of policies relating to patients’ access to their protected health information.
If you’d like to read plain English press coverage of the JAMA study:
- The Unfortunate Truth About Getting Your Medical Records, by Harlan Krumholz, MD (one of the study authors, writing for Forbes).
- For U.S. patients, access to medical records often difficult and costly, by Linda Carroll (Reuters).
Another perspective worth attention comes from Lucia Savage, a former colleague of mine at HHS and now Omada Health’s Chief Privacy and Regulatory Officer. She spoke with Jessica Davis of HealthCare IT News:
There are many issues when it comes to data sharing, including contractual data blocking by vendors. It’s understudied, but Savage explained that it’s likely more prevalent than imagined. Health data is like “intellectual oil” powering an “idea economy.”
“So the person who has the data feels like they have something special. And there are a lot of pieces on how that gets played out,” she said. For example, an EHR vendor may take a blood sugar reading and how they display it is their intellectual property.
“But what your blood sugar was, is what your blood sugar was: It’s just PHI,” she continued. “We don’t have very refined rules for separating those things out. … People are sort of asserting a property or proprietary interest over data that comes from the natural process of being a human being.”
Another issue is the way ideas and inventions interact within healthcare, such as a device. Savage explained devices aren’t necessarily covered by HIPAA, so the manufacturer isn’t directly subject to those rules that “let you get your own data.”
Only once the data has flowed into the EHR can the patient get it, she explained. “But the device manufacturer just is collecting data and analyzing it on their servers. And it literally is physically and legally their property.”
Another of my former HHS colleagues, Deven McGraw, wrote a great health data rights explainer on the Ciitizen blog, the startup she joined (and again, full disclosure, I’m advising). For example:
- With a few exceptions (that so rarely occur they probably don’t apply to you), you have the right to all of your health information from your medical providers and your health plans. Doesn’t matter how old it is, or where it originated – if they have the information you’re requesting, you have a right to it.
- You have the right to an electronic copy of any information that is maintained electronically (such as in an electronic medical record) – and you even have the right to have paper copies scanned into an electronic format (such as pdf) if the institution or organization has scanning capabilities.
- You have the right to get your health information sent to you by e-mail – even if your e-mail isn’t secure, as long as you acknowledge that you are comfortable with receiving your health information this way.
We know that when people gain access to the internet, they dive in quickly to health information searches. Recent surveys show that we’re now at near-universal internet access in the U.S. and most people say they go online to look up all kinds of information. What’s particularly intriguing to me are those who look online for someone who shares the same health condition or concern — the just-in-time someone-like-me who can give them peer advice tailored to their needs. How might we leverage that instinct for connection? How might data play a role? How might we grow people’s appetite for health engagement?
The elephant in the room is that most people don’t WANT to engage in their health, much less with their health data. Highly motivated patients and caregivers are the tip of the spear, the pioneers who will push for access and help create the tools that the rest of the population will gratefully use if they ever need them. I still believe we should all be working toward freeing the data and letting people decide whether to engage with it, building the infrastructure and tools that allows someone to wake up one day (maybe because of a life-changing diagnosis) and say, “Yes, I’m ready. Now, how do I get my data?”
* spotted a tweet by Liz Salmi with the new number for OpenNotes (31 million patients) and: “We hit all 50 states on Friday with the addition of a health system in Alabama—Auburn U.”
UPDATE: Video of our panel is below
Featured image: “Medical records closes at 5:00pm on Friday” by Regina Holliday.
We should be able to participate in provider-to-provider conversations on electronic medical records. Often, my doctors talk to each other about issues that, they’d all agree, I know most about. The fact that I can’t participate in those conversations about my own issues is not only wrong, it’s also highly inefficient. In the case of my doctors, they’d like to include me, but the EMR makes it impossible.
Thanks, Emily! That’s a worthy problem for people to work on. I wonder if there are health systems who have found work-arounds.
(Note to people reading this: please jump in if you have ideas!)
> In the case of my doctors, they’d like to include me,
> but the EMR makes it impossible.
One possibility: mandate that the EMRs enable the patient (or their parent/proxy/caregiver) to be a participant in the conversation.
I know some providers would hate it. One possibility.
Heck, let Epic et al charge another $100k for that module too.
Dave is right. The Emerging Leaders Program project idea my partner and I came up with for Medicine X had a useful idea that could be used to facilitate what Dave mentioned — patients joining the conversation. Basically, just as Twitter has “Tweets” and “Tweets and Replies” filtering so you can see what’s going on, it would be easy to have a similar filter — one that allows patient participation in the conversation and one that shows you just the clinical record generated by providers of all types. Oh, and instead Dave, Emily, and I could split the $100K with you, instead of Epic, Susannah!
At times, so does HIPAA
Nice of you to let a token man be on that panel
Noticed that, did you? I’m such a fan of all my co-panelists, not least because of their appearances on a couple of my favorite podcasts: Pulse Check and Tech Tonics. Here’s the lineup for those cramming for tomorrow’s session:
Politico’s Pulse Check: Dan Diamond’s interview with Don Rucker: The national coordinator for health IT says it’s past time to empower patients to get their data.
Tech Tonics: When Lisa Suennen and David Shaywitz talked with Iya Khalil I had to listen to it twice it was so packed with insights.
Tech Tonics: I love how Deborah Kilpatrick describes how she navigated engineering, medical device innovation, and now digital health in yet another awesome interview with Lisa and David.
Such a great post – I love visuals! And to me, the metaphor of protecting one’s ‘intellectual oil’ via contractual data blocking emotes a visual of Daniel Day-Lewis’ 2007 oil baron drama “There Will Be Blood.” I’m now struggling to get the image of (insert EHR CEO name here) screaming “I’ll drink your milkshake – I’ll drink it up!” out of my head. HA!
In all seriousness, we are in a moment in time where the unfortunate reality is our health data is more valuable to specific business models than the overall outcomes of the individual we serve. I’ve had direct and frank conversations with “leaders” in this industry who have told me: “Sharing data (i.e., intellectual property) and running for-profit businesses are diametrically opposed.” I firmly believe it was in these conversations where I decided my new mission in life is to Liberate the Data.
I’ve heard 3 lies evolve throughout my HIT career: 1) Health, 2) Care, 3) System. Firstly, it wasn’t until very recently where ‘health’ became a focal point centered around quality. Secondly, quite often it seems more attention is paid to costs, margins, revenues, savings, and covering one’s own liabilities rather than the ‘care’ itself. I’ve had conversations with providers who would have rather not known certain details about their patients because of a fear of becoming legally liable in certain cases. I wrote a blog about it here: http://www.holonsolutions.com/scar-tissue-better-brain-tissue/ Thirdly, this is no ‘system,’ these are merely amalgamations of siloed data islands which at times check the regulatory box when pushed to share so as not to get penalized.
I believe people need to stand up and get mad. I have come to realize it is up to us – the people – ‘we the patients in order to form a more perfect health care system…’ cannot wait for those holding the data to one day feel altruistic and begin to open their systems to us. Instead, we must fight to reimagine interoperability in real-time and liberate the data in order to liberate the care. The tools are out there. The technology for accomplishing this is real. We need to stand together. I for one will be fighting tirelessly for the underdog who is underserved by this fragmented and siloed system we call HIT.
Thank you! Love the passion and the mission. Let’s keep going!
> My essential message is that patients and caregivers
> should be as much a part of the disruption conversation
> as any other stakeholder.
OMFG. 1) Yes. 2) Obviously. 3) I assert that in any industry, if the ultimate stakeholder ISN’T in the conversation, then it’s NOTHING but “elbow hockey” among players who are fighting over varying shares of our flesh and the revenue that others can extract from our needs. Seriously. And that may be beneficial but it can also be highly immoral or just grossly unfair.
Knowledge is power. Data is power. Power to the people.
As you know, I was in the graphic arts when desktop publishing disrupted the industry by putting actual power (power to set priorities!) in the hands of the people who had the need (for a brochure, a newsletter, what have you). What happened (a radical restructuring, not just of the industry but of workflows!) would not have been possible if the “disruption” had been among new and existing players who were trying to grab shifting shares of EXISTING power structures and workflows.
This is why back in 2009 when I tried to seed similar disruption by getting my data, and my data turned out to be utterly mismanaged CRAP, I cried “Gimme my DaM data” (data about me). NOTHING would be improved by letting more vendors play elbow hockey with my mismanaged data.
Market insurgents do not equal disruption.
And it’s why in 2015 I blogged on GetMyHealthData that I want nothing short of a SPIGOT – a health data spigot. http://bit.ly/healthspigot No freaking intermediaries; give US our data.
And then this week at #SPM2018, two separate mother-daughter cases illustrated the importance of absolutely unfettered patient access – the stories of Kristina and Kate Sheridan (overcoming an overwhelming and incapacitating Lyme case through extraordinary wrangling of health data) and Angela and Grace Kennedy.
Both of those cases were applications of managing a daughter’s health data in ways that had ZERO MARKET POTENTIAL because only one person was in big trouble, so depending on “market forces” would have been an utter disservice. That’s IMO the whole point – market dynamics are a s@#$ty algorithm for solving the needs of individuals. Population segmenting and disease frequency are the forces that drive grant funding and investments, and they steamroller crush anyone who doesn’t belong to the privileged(?) class of popular diseases.
And all that is why after years of being unsatisfied, in 2018 I’ve become rabidly in favor of truly consumer-directed data flows and workflows such as what Apple is doing and the FHIR people are doing. I’m speaking at FHIR Dev Days in Amsterdam next month (no pay; in fact, buying my own plane ticket & hotel) to tell the developers that WHATEVER they do, let the consumer / patient tap a spigot into the pipe and get 100% of it, to do whatever they want with.
Just as surely as I wrote about this nine years ago, I guarantee that a lush pond of apps will spring up – some of them for a class of people and some of them for n-of-1 cases like Angela’s, and another guy I just met this week. What they’ve done and will do will blow people away, demolishing the idea that only big highly educated players can do anything valuable in healthcare.
Not that you asked … 🙂
______________
p.s. For a really deep dive into the arguments from 2010 that are finally flowering, pack a lunch and chase the links in this post.
“Gimme my damn data!” The stage is being set to enable patient-driven disruptive innovation. Excerpt:
Yes, yes, and yes. Thanks, Dave, as always for bringing the footnotes to the party. This post is getting close to that tipping point when there’s more interesting stuff in the comments than in the original essay. I’d love to keep the conversation going and promise to add what is discussed during the panel, too.
I wish someone would either argue with me or agree with me on “Market insurgents do not equal disruption.” This is a core distinction.
People don’t KNOW what disruption is until they’ve been run over by it. I was, and I learned (in the end) how wrong I’d innocently been. Once you’ve seen that, it’s very unsatisfying to watch outsiders (players with no “ground truth” stake in the work) jostling for position while thinking they’re changing lives. They’re not. And in healthcare, BOY is that important.
Additional links I forgot to include there:
Angela Kennedy’s post for #SPM2018 https://participatorymedicine.org/epatients/2018/10/spm2018-speakers-_angelakennedy-and-daughter-grace-personal-health-information-is-saving-grace.html
The 4/1/2009 post where I discovered my hospital had sent mismanaged CRAP to Google Health (hence “because you guys can’t be trusted with it”) https://participatorymedicine.org/epatients/2009/04/imagine-if-someone-had-been-managing-your-data-and-then-you-looked.html
Interesting piece, thanks for sharing. I agree that involving all parties should lead to better healthcare across the field for all those involved, notably the patient. However (always a however when it comes to data & disruption), your point about the elephant in the room is extremely valid.
What needs to happen here, and I’m only seeing this ever so rarely in a clinical setting, is a mental and cultural shift in the role of the patient. The ideology of the doctor being the main gate keeper of all ones medical information is going to be out dated, to some extent. The onus of responsibility is shifting to a truly patient centred care model & not just a doctor-dictate-down model. The new patient, we (health care professionals HCP & care givers & doctors etc) hope can be motivated and involved in their health care. The shift also applies to the doctor and other parties involved. Where does this education begin? Medical school?
As much as digital health & EHealth systems are emerging there is still that lag time of the mental and cultural shift for patients to take on their data & responsibility. For patients with large health record files this can be a daunting processes. In fact, for any size health record file, having access can be confronting. It is sometimes easier for patients to rely on their doctors and HCP recommendations without questioning… and for doctors and HCPthe shift In power is another cultural and mental evolution.
Data and disruption in the healthcare fields is still a relatively new subject and the early adopters are certainly making waves. However as more peoole use online healthcare services, and read more and as you have said, freely share and ask for patient to patient recomendarions.. the new digital patient will evolve.
Perhaps this is the new digital patient & future of health that is being created. Time will tell & certainly the value of personal data will emerge.
Hi Kat – I don’t think we’ve crossed paths!
Your thoughts align precisely with what we’re trying to do in the Society for Participatory Medicine, transforming the culture of care.
I have a different view of the elephant, though. I think its fair to say that nobody wants to engage in ANYTHING until they discover one way or another that engaging makes any difference, whether it’s oil changes on a car or anything else. Then once they do realize it, the simplicity of doing the right thing makes all the difference, yes? (I’m thinking most recently of convenient flu shots.)
Susannah cites what innovators call “early adopters” as the tip of the spear. What intrigues me most is what’s newly possible, as personified by those people, and the flip side of that is how fascinating it is that well trained people can deny those possibilities because they don’t often spot them! IMO the real juice on improving health and care is in asking “Hey, what just happened there?? That was neat! How can we create more of that??”
Returning to the data topic, it’s clear to me (from personal experience and many others’ stories) that knowledge is power, thus data is power, and (as I said in my 2013 book Let Patients Help), it’s perverse to keep people in the dark and then observe that they’re naive.
I’m also a big fan of the literature about the Patient Activation Measure (PAM) – have you seen it? An important aspect is about interacting differently with people based on whether they BELIEVE anything they do makes a difference. I’d love to see a study of whether there’s a correlation between PAM score and interest in one’s health data, and I REALLY wish we had longitudinal data about that over the past decade!
btw, for those who don’t know the PAM, Susannah first blogged about it when it was new, citing a 2007 study. Today PubMed shows over 200 hits for the term, with >40/year recently.
Side note on the PAM:
It was developed in the early 2000s thanks to funding from the Robert Wood Johnson Foundation and is now only available for use by those who license it from Insignia Health ($4,500 for up to 500 unique individuals. $7,500 for 501 – 1,000 unique individuals.)
See: Development of the Patient Activation Measure (PAM): Conceptualizing and Measuring Activation in Patients and Consumers (Health Services Research, 2004)
It has always struck me as odd that foundation funding fueled the development of a commercial product, but perhaps someone who knows more about the history can educate me as to why. I suppose a corollary is that government funding has fueled the development of many commercial products (including drugs and other treatments) and we citizens even have to pay to read the journal articles about those advancements. One question is: Are times changing?
I’ve heard talk over the years about the possibility of creating an open-source measure that would be more widely available for use. If anyone reading this knows more, please add a comment.
I had not known that aspect of the PAM origin. I agree, that seems odd.
Here’s a thread on the ResearchGate forum. Are there alternatives to Insignia Health’s “Patient Activation Measure” (PAM)? A message from a Peter Liepmann (can’t link to it) has links to other tools.
An employer collaborative a few years ago was developing something similar to PAM.
Hi Dave, great to meet you and thanks for sharing your detailed points herein.
I have not seen the PAM thanks for bringing that to my attention. I enjoy the recommended readings and will tend to those shortly.
What I was trying to convey and you have said it nicely, power to the people!!
My concerns;
– Tech start ups are building online services or shops based on short sighted profits and hence their fails;
– similar for health care providers;
– people not quite ready for online health (even though there is mounting evidence to show trends online, the conversion may not quite be there);
– some people don’t care what happens to there data. A lot of people I speak too comment “it won’t happen to me” or “it’s just data, it’s not that valuable”. And herein lies my issue with both the provider and receiver side. We need better regulations so patient data cannot be exploited.
Too late?
May be.
Insurance companies basing policies soley on wearable data (https://www.forbes.com/sites/enriquedans/2018/09/21/insurance-wearables-and-the-future-of-healthcare/#5fdadd261782)… change is inevitable and we’ve (all involved) got to take responsibility and not let companies ditacte how things will be run.
Thank you for continuing the conversation (and double thanks for everyone’s patience with comment moderation — I have to approve first-timers and any comment with a link. A challenge when I’m also attending a conference 🙂
btw, in a 2014 email from Insignia rep Craig Swanson, he said that PAM licenses are half price if the user will share anonymized responses back into the PAM database.
Not sure how much work that involves – just passing it along.
First, holy WOW that Undark Mag piece – it felt a little PTSD for me after being Leah to both my parents in the last several years of their lives.
My concerns about data-siloing (by EMR and other related health IT vendors) and data-blocking (by ditto) have been exacerbated over the last couple of years in the rise of what’s now being called the “health data gold rush” (good piece on this from The Scientist: https://www.the-scientist.com/bio-business/startups-plan-the-health-data-gold-rush-64840), which data gold rush I’ve been banging on about for a while now (to wit: https://medium.com/@mightycasey/selling-my-health-data-cut-me-in-bitches-447880201004).
Here’s the thing, in my view at least: we’re at a watershed moment with the impact of all the data that we, the citizens of nations and the world, spew on the daily as we go about our daily lives. Will all that data be weaponized against us, and used by the few to rule the many?
On the strictly-health-data front, the money is running the game, too, it’s not just algorithms to better flog products and services at us. Not many outside our small band of cyber-woke folx noticed when NPR rang alarm bells about this back in July (https://www.npr.org/sections/health-shots/2018/07/17/629441555/health-insurers-are-vacuuming-up-details-about-you-and-it-could-raise-your-rates), which IMO is even more of a threat to civil rights than anything Cambridge Analytica pulled off.
Back the actual topic here – data as an engine of disruption in healthcare. Our health information is our most intimate data (well, other than porn viewing history, but that’s a story for another blog post), but every Bob & Carol & Ted & Alice Inc. is minting coin off exchanging that data with each other, while giving the people whose data it is access to versions of it that are mostly useless (no interop potential, and only in small slices). “Disruption” has too often meant tech innovation that is AWESOME for its creators (hello, FAANG, I’m looking at you), but the jury’s still out on whether it was a blessing or a curse for the average human using this “new thing.”
Bottom line: give me my data. ALL of it. And give me equal ownership rights to its commercialization and use. Most particularly my medical/health data. Nothing short of that will balance the power paradigm in the data economy enough to prevent a mashup of Brave New World and 1984, with a heaping side dish of The Hunger Games.
Casey, you should just put your danged comments behind a paywall, they’re so hot. But I know you won’t. Just thanks.
Suzanna – is this correct?
“But the device manufacturer just is collecting data and analyzing it on their servers. And it literally is physically and legally their property.”
Have the device mfrs ever withstood a HIPAA challenge? How about a state health dept challenge? Is there a precedent set?
I could really use some info. I have both complaints currently under investigation.
My CE and the BA tell me that their BAA is confidential – how is that legal? Why can’t I be informed of the privacy practices in place which manage my original device data? This makes no sense to me.
Thanks for the question, Gretchen! I will ping Lucia Savage, whose quote you are referencing, to see if she can amplify her remarks.
Thank you! If Ms. Savage is correct, we patients are being exploited for our data. Medical device remote monitoring is a predatory business practice – there is no disclosure or transparency provided to patients. We can’t shop around for the RM service which best meets our needs. I have no idea what data is being harvested from my device. I have requested my full medical record as held by a device mfr & transparency into the RM service. Legal counsel for the mfr’s response, “…really is not your data.”
Huh? I participate in RM at the instruction of my EP. I don’t have an independent usage agreement w/the mfr where I signed away the rights to my data.
My hospital’s Chief Privacy Officer isn’t helping me navigate through this mess either. I get non-answers which read like they have been edited by several attorneys.
I’m living a “Kafkaesque situation” – that’s a quote from HHS OIG Counsel.
Lucia is appearing on a panel this morning so messaged back on Twitter with a link to FDA guidance related to device data:
“The FDA issued the final guidance on Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request to clarify that FDA requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved and/or derived from a legally-marketed medical device with the patient who is either treated or diagnosed with that device. The policy described in the guidance applies to medical devices that store inputs from health care providers regarding the status or ongoing treatment for a patient and to medical devices that directly record information about usage, alarms or outputs. The FDA expects that patients would be most interested in access to information from devices that monitor physiological signals that can relate to health outcomes (e.g., pulse oximeters, blood pressure monitors, heart rhythm monitors, hemodynamic recording systems, electroencephalograms, sleep diagnostic devices, etc.).”
My interpretation of the guidance: Don’t hide behind the FDA. They want consumers to have access to their data.
Hi Suzanna,
I forwarded that guidance over to the mfr’s attorney last year & an FDA Ombudsman tried to help me get access to my data. No dice – the attorney wouldn’t budge.
Could their refusal really be the mfr’s attempt to protect the RM revenue stream? I’ve read the HHS website & the law. I just can’t find a legal basis w/in HIPAA for their continued refusal. If they had a legal argument, I believe they would have cited it already.
I suspect that it is just tradition, standard business practice & agreements w/EPs, rather than based in HIPAA law.
What is your opinion? Does the device mfr have HIPAA law on their side?
We’re at the end of what my WordPress template allows for replies so I’m sticking this answer above your latest question. And unfortunately it’s not much of an answer: I don’t know. HIPAA is not my area of expertise. Good luck!
In financial and economic sense, a Patient unless treated totally for free, paid for his or her treatment and, therefore, medical data as part of that treatment. Doesn’t matter if it the cost was paid by a govt or private insurance on-behalf of the #patients or out-of-pocket. Even if logic does not convince so many literate people in #Healthcare, this factual argument could be used to transition ownership to the actual owner of medical data: the #patient! not !
My concern with this is that it means that patients who enter into research studies and who are treated for free might not understand the implications. They are also likely to be patients in a more vulnerable position because of social determinants, medical need/urgency and so forth. While great work on bringing informed consent to the digital sphere has been and is being done, there’s still work to do.
A recent conversation with @Susannah prompted some ideas and work around helping patients, researchers, and clinicians grapple with complex informed consent requirements so that all parties benefit. The goal is to develop an open, universal standard that governs how consent rules are depicted and honored across the diverse sphere of data. It’s meant to be extensible to cover other data associated with our identity, purchasing, behavior, economic circumstances.
We all know that these data are bought and sold, mixed and matched, correlated by buyers and sellers of the data, usually with the individual excluded from the value chain.
The key, in my opinion, to igniting the Renaissance in personal data science and unlocking the real value is to help people understand the potential impacts of their consent choices with a large, variable set of interrelated parameters. Looking forward to inviting others to help out soon; especially patients!
Data, data, data. I often download my own medical . record, one from Humana and the other from my provider. The Humana site is usually spot on, while my provider’s portal information is usually inaccurate and incomplete. I see four providers and they spend substantiaI time treating their computer screen and keyboaord, yet I cannot find the content for each medical visit. and the past medical history is incomplete, which is a big surprise since the first time I went there I filled out a very complete form detailing all my history, surgeries and other events. Obviously this was not included in the PMR. Perhaps it was scanned in, but I could not find it. The EHR was originally designed to afford a more permanent and legible record. It was never meant to be a collector of data. CMS and HMS kidnapped it by funding ONC and certification in order to be eligible for incentive grants to providers who purchased the programs. Providers were forced to purchase poorly designed systems not optimized for patient care. Vendors were forced to invest in data acquisiton to satisfy CMS, HHS, not for provider nor patient welfare. In 2005 I wrote about this when David Brailer MD was the original ONC.