The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking as part of implementing the 21st Century Cures act. In this series we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.
Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.
This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications. Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.
Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.
On one hand, regulators are reluctant to limit private corporate action lest we reduce innovation and patient choice and promote moral hazards. On the other hand, a privatized marketplace for services requires transparency of costs and quality and a minimum of economic externalities that privatize profit and socialize costs.
For over two decades, the HIPAA law and regulations have dominated the way personal health data is used and abused to manipulate physician practice and increase costs. During these decades, digital technology has brought marvels of innovation and competition to markets as diverse as travel and publishing while healthcare technology is burning out physicians and driving patients to bankruptcy.
Abbott Ventures chief Evan Norton may have spent part of his youth on a farm, but there’s no manure in his manner when speaking of the medical device and diagnostics market landscape. The key, he says, is to avoid being blindsided by the transformational power of digital data.
“We’ve been competing against Medtronic and J&J, so that has the risk of us being disintermediated by other players that come into the market,” Norton told attendees at MedCity Invest, a meeting focused on health care entrepreneurs. “Physicians are coming to us and asking for access to data for decisions, and they don’t care who the manufacturer [of the device] is. Are we enabling data creation?”
Abbott, said Norton, wrestles with whether they are simply data creators or want to get paid for providing algorithmic guidance on how the data is used. (Full disclosure: I own Abbott shares.) Other panelists agreed making sense of the digital data deluge remains the central business challenge.
What’s received little attention from physicians or the public is the company’s quiet metamorphosis into a powerhouse focused on the actual practice of medicine.
If “data is the new oil,” as the internet meme has it, Google and its Big Tech brethren could become the new OPEC. Search is only the start for Google and its parent company, Alphabet. Their involvement in health care can continue through a doctor’s diagnosis and even into monitoring a patient’s chronic condition for, essentially, forever. (From here on, I’ll use the term Google to include the confusing intertwining of Google and Alphabet units.)
Amazon has transformed the way we read books, shop online, host websites, do cloud computing, and watch TV. Can they apply their successes in all these other areas to healthcare?
Just last week, Amazon announcedComprehend Medical, machine learning software that digitizes and processes medical records. “The process of developing clinical trials and connecting them with the right patients requires research teams to sift through and label mountains of unstructured clinical record data,” Fred Hutchinson CIO Matthew Trunnell is quoted saying in a MedCity News article. “Amazon Comprehend Medical will reduce this time burden from hours to seconds. This is a vital step toward getting researchers rapid access to the information they need when they need it so they can find actionable insights to advance life-saving therapies for patients.”
Deriving insights from data and making those available in a user-friendly way to patients and clinicians is just what we need from technology innovators. But these tools are useless without data. If an oncology patient is hospitalized, her provider may not be informed of her hospitalization for days or even weeks (or ever). And the situation is repeated for that same patient receiving care from cardiologists, endocrinologists, and other providers outside of her oncology clinic. When it comes to personalized health and medicine, both the quantity and quality of data matter. Providers need access to comprehensive patient health data so they can accurately and efficiently diagnose and treat patients and make use of technology that helps them identify “actionable insights.”
Making Sense of Blue Button, Meaningful Use, and What’s Going on in Washington …
At the recent Health 2.0 Conference in Santa Clara, co-chair Matt Holt expressed frustration about the difficulty of getting copies of his young daughter’s medical records. His experience catalyzed a heated discussion about individuals’ electronic access to their own health information. Many people are confused about or unaware of their legal rights, the policies that support those rights, and the potential implications of digital access to health data by individuals. The Health 2.0 conference crowd included 2000 entrepreneurs, consumer technology companies, patient advocates, and other potentially “disruptive” forces in healthcare, in addition to more traditional health system players.
Why is this topic so important? Until now, most people haven’t accessed their own health records, whether electronically or in paper, and I believe that making it easier to do so will help tip the scales toward more meaningful consumer/patient engagement in healthcare and in health. Access by individuals and their families to their own health records can empower them to coordinate care among multiple healthcare providers, find and address dangerous factual errors, and take advantage of a growing ecosystem of apps and tools for improving health-related behaviors, saving money on health services, and getting more convenient, personalized care.
A shorthand phrase for this kind of personal empowerment through access to digital health data is “Blue Button,” which is also the name of a public-private initiative in which hundreds of leading healthcare organizations across the US participate. The Blue Button Initiative is bolstered by the electronic access to health information requirements for patients in the “Meaningful Use” EHR Incentive Program, which is administered by CMS (the Centers for Medicare & Medicaid Services) with companion standards and certification requirements set by ONC (the Office of the National Coordinator for Health Information Technology).Continue reading…
Recently the Centers for Medicare and Medicaid (CMS) made troves of data publically available. CMS released data on hospital charges, physician utilization, in addition to other data sets. Journalists and academics were excited to potentially confirm their theories on healthcare spending.
We at The Engelberg Center hosted an event, Hacking America’s Health where experts from the Brookings Institution and the government spoke to participants regarding the impacts of data transparency on the nation’s healthcare system. The purpose of the festival is to focus on “innovators from around the world and their transformative solutions to global challenges.”
Out of this discussion emerged a consensus that data transparency could spur disruptive innovation in the health sector but overcoming several key barriers was essential to maximizing the benefits to the public.
Benefits of Data Transparency
1. Help Consumers Make Informed Decisions
Open data offers numerous benefits to consumers. The CMS data unveils the enormous variation in the cost of different treatments. Enabling consumers to find high value care providers improves the efficiency of the market. Price transparency can also uncover providers that charge unusually high prices and puts pressure on them to lower those charges. Finally utilization can reveal if a doctor uses a rare treatment with regularity. All of these data empower health care consumers to choose wisely.
2. Identify Vulnerable Patients
CMS has used open data for numerous projects to help patients. One project involves collaboration with local and state governments. Using Medicare claims information they identified specific patients who could be in special danger in the aftermath of a natural disaster. Without electricity it’s impossible to operate a lifesaving device like a ventilator or nebulizer. The claims data allows emergency officials to notify such individuals about the locations of shelters.
3. Data Mashups
Combining together data sets could help identify bad actors in the health system. For example merging data from the Sunshine Act which describe payments and items given to physicians combined together with utilization data from CMS. This could identify doctors who were using a drug or procedure due to a financial relationship rather than best practice. Other data mashups could also uncover unexpected patterns.
Patients who search on free health-related websites for information related to a medical condition may have the health information they provide leaked to third party tracking entities through code on those websites, according to a research letter by Marco D. Huesch, M.B.B.S., Ph.D., of the University of Southern California, Los Angeles.
The research letter was recently published in JAMA Internal Medicine entitled “Privacy Threats When Seeking Online Health Information” and looked at how 20 health-related websites track visitors, ranging from the sites of the National Institutes of Health to the health news section of The New York Times online. Thirteen of the sites had at least one potentially worrisome tracker, according to the analysis performed by Dr. Huesch.
He also found evidence that health search terms he tried — herpes, cancer and depression — were shared by seven sites with outside companies. According to the paper:
“A patient who searches on a “free” health-related website for information related to “herpes” should be able to assume that the inquiry is anonymous. If not anonymous, the information knowingly or unknowingly disclosed by the patient should not be divulged to others.
Unfortunately, neither assumption may be true. Anonymity is threatened by the visible Internet address of the patient’s computer or the often unique configuration of the patient’s web browser. Confidentiality is threatened by the leakage of information to third parties through code on websites (eg, iframes, conversion pixels, social media plug-ins) or implanted on patients’ computers (eg, cookies, beacons).”
Dr. Huesch says that he was inspired to investigate this area by the archive of coverage on the topic by The Wall Street Journal on how the technology and market for your online information work. The most recent piece in this series is on Facebook privacy settings and some of the risks associated with “Graph Search.” This entire series is very good and worth the read.
The latest news story to examine the issue of patient access to implantable cardiac defibrillator data (a variation on the theme of “gimme my damn data”) is an in-depth, Page One Wall Street Journal story featuring Society for Participatory Medicine members Amanda Hubbard and Hugo Campos. They have garnered attention in the past – one example is another piece on Hugo on the NPR Shots blog about six months back. The question posed by these individuals is simple — May I have access to the data collected and/or generated by the medical device implanted in my body? — but the responses to the question have been anything but. It is important to note that not every patient in Amanda’s or Hugo’s shoes would want the data in as detailed a format as they are seeking to obtain, and we should not impose the values of a data-hungry Quantified Self devotee on every similarly-situated patient. Different strokes for different folks.
The point is that if a patient wants access to this data he or she should be able to get it. What can a patient do with this data? For one thing: correlate activities with effects (one example given by Hugo is his correlation of having a drink of scotch with the onset of an arrhythmia — correlated through manual recordkeeping — which led him to give up scotch) and thereby have the ability to manage one’s condition more proactively.
In a few days, I will be releasing the most controversial healthcare project I have ever worked on. But you do not need to take my word for it. I will be releasing a completely new healthcare data set. That data set, which will remain a “Mystery Data Set” until its release to the healthcare data scientists attending Strata RX, should completely revolutionize the way we think about healthcare delivery in the United States.
This mystery data set is the first real outcome of the Patient Skunkworks project. Patient Skunkworks is a new way for me to try and create high-impact but low-profit software projects. This is part of a new Not Only For Profit software development model that I have been working on. The new company forming to do this work will be called Not Only Development.
I will be releasing this data during the last keynote on the first morning (Oct 16) of the 2012 Strata RX conference. There is simply no way, in a single keynote, to even begin understanding all of the ways that this data set will be leveraged to improve healthcare. More importantly, there is really no way to adequately explain why I would choose to give away such a valuable and dangerous data set.
To help people digest the implications of this data set, I will be writing two articles about the data set. This one, before the release which helps to explain the underlying motivation behind the release, and another one after the release explaining what the data set is, and how I think it can be leveraged.
I am releasing this dataset because I believe that the only way to solve the problems in healthcare is to embrace a radical openness with health data. Healthcare data, with the exception of patient identity data, belongs in the open, in the sunlight. When used correctly, I believe that healthcare data should make patients feel empowered, and everyone else in the healthcare industry uncomfortable. I believe that patients deserve deep, dangerous and real access to data. I think when we start talking about how data might actually be dangerous for patients, its just a sign that we are “doing it right”. I call this concept Radical Access to Data (and yes, that recursively spells “RAD”).