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Information Blocking–The AHA Comments & PPR Responds

The focus on the CMS rules on information blocking continues on THCB. We’ve heard from Adrian Gropper & Deborah Peel at Patients Privacy Rights, and from e-Patient Dave at SPM and Michael Millenson. Now Adrian Gropper summarizes — and in an linked article –notates on the American Hospital Association’s somewhat opposite perspective–Matthew Holt

It’s “all hands on deck” for hospitals as CMS ponders the definition and remedies for 21st Century Cures Act information blocking.

This annotated excerpt from the recent public comments on CMS–1694–P, Medicare Program; Hospital Inpatient Prospective Payment Systems…  analyzes the hospital strategy and exposes a campaign of FUD to derail HHS efforts toward a more patient-centered health records infrastructure.

Simply put, patient-directed health records sharing threatens the strategic manipulation of interoperability. When records are shared without patient consent under the HIPAA Treatment, Payment and Operations the hospital has almost total control.Continue reading…

Self-Driving Cars are Like Most EMRs

by HANS DUVEFELT, MD

Drivers are distracted klutzes and computers could obviously do better. Self driving cars will make all of us safer on he road.

Doctors have spotty knowledge and keep illegible records. EMRs with decision support will improve the quality of healthcare.

The parallels are obvious. And so far the outcomes are disappointing on both fronts of our new war against human error.

I remember vividly flunking my first driving test in Sweden. It was early fall in 1972. I was in a baby blue Volvo with a long, wiggly stick shift on the floor. My examiner had a set of pedals on the passenger side of the car. At first I did well, starting the car on a hill and easing up the clutch with my left foot while depressing and then slowly releasing the brake pedal with my right forefoot and at the same time giving the car gas with my right heel.

I stopped appropriately for some pedestrians at a crosswalk and kept a safe distance from the other cars on the road.

A few minutes later, the instructor said “turn left here”. I did. That was the end of the test. He used his pedals. It was a one way street.

Three times this spring, driving in the dark between my two clinics, I have successfully swerved, at 75 miles (121 km) per hour, to avoid hitting a moose standing in the middle of the highway. Would a self driving car have done as well or better? Maybe, maybe not.

Every day I get red pop up warnings that the diabetic medication I am about to prescribe can cause low blood sugars. I would hope it might.

Almost daily I read 7 page emergency room reports that fail to mention the diagnosis or the treatment. Or maybe it’s there and I just don’t have enough time in my 15 minute visit to find it.

For a couple of years one of my clinics kept failing some basic quality measures because our hasty orientation to our EMR (there was a deadline for the incentive monies to purchase EMRs) resulted in us putting critical information in the wrong “results” box. When our scores improved, it had nothing to do with doing better for our patients, only clicking the right box to get credit for what we had been doing for decades before.

Our country has a naive and childish fascination with novelties. We worship disrupting technologies and undervalue continuous quality improvement, which was the mantra of the industrial era. It seems so old fashioned today, when everything seems to evolve at warp speed.

But the disasters of these new technologies should make us slow down and examine our motives. Change for the sake of change is not a virtue.

I know from my everyday painful experiences that EMRs often lack the most basic functionalities doctors want and need. Seeing a lab result without also seeing if the patient is scheduled to come back soon, or their phone number in case they need a call about their results, is plainly speaking a stupid interface design.

I know most EMRs weren’t created by doctors working in 15 minute appointments. I wonder who designed the software for self driving cars…

Hans Duvefelt is a family doctor in Maine. This piece was first published at his blog A Country Doctor Writes

Information Blocking–Gropper & Peel Weigh in

Deborah C. Peel
Adrian Gropper

Today is the last day for public comments on the proposed CMS regulations regarding Medicare hospital inpatient prospective payment systems (IPPS). While there are several changes proposed, the one that’s raised lots of attention has been the idea that access to Medicare may be denied to those providers guilty of information blocking. Here are the comments submitted by Gropper & Peel from Patients Privacy Rights— Matthew Holt

Executive Summary of PPR Comments on Information Blocking

Information blocking is a multi-faceted problem that has proved resistant to over a decade of regulatory and market-based intervention. As Dr. Rucker said on June 19, “Health care providers and technology developers may have powerful economic incentives not to share electronic health information and to slow progress towards greater data liquidity.” Because it involves technology standards controlled by industry incumbents, solving this problem cannot be done by regulation alone. It will require the coordinated application of the “power of the purse” held by CMS, VA, and NIH.

PPR believes that the 21st Century Cures Act and HIPAA provide sufficient authority to solve interoperability on a meaningful scale as long as we avoid framing the problem in ways that have already been shown to fail such as “patient matching” and “trust federations”. These wicked problems are an institutional framing of the interoperability issue. The new, patient-centered framing is now being championed by CMS Administrator Verma and ONC Coordinator Rucker is a welcome path forward and a foundation to build upon.

To help understand the detailed comments below, consider the Application Programming Interface (API) policy and technology options according to two dimensions:

API Content and Security Institution is Accountable Patient is Accountable
API Security and Privacy
  • Broad, prior consent
  • Patient matching
  • Institutional federation
  • Provider-directed interop
  • Compliance mindset
  • Directed authorization
  • Known to the practice
  • Individual credentials
  • Patient-directed interop
  • Privacy mindset
API Content / Data Model
  • Designated record set
  • FHIR
  • Patient-restricted data
  • De-identified data
  • Bulk (multi-patient) data
  • Designated record set
  • FHIR
  • Sensitive data
  • Social determinants
  • Wearables and monitors

This table highlights the features and benefits of interoperability based on institutional or individual accountability. This is not an either-or choice. The main point of our comments is that a patient-centered vision by HHS must put patient accountability on an equal footing with institutional accountability and ensure that Open APIs are accessible to patient-directed interoperability “without special effort” first, even as we continue to struggle with wicked problems of national-scale patient matching and national-scale trust federations.

Here are our detailed comments inline with the CMS questions in bold:Continue reading…

Defining Engagement in an Age of Patient Monitoring and Data Collection

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What is healthcare without patients? For decades physicians have been a one-stop shop for diagnosis and treatment, a trusted source. And yet it’s only been in recent years that the entire healthcare industry has woken up to the notion that patients can and should have an active role in their healthcare and the decision making process. Patients may not have a medical education or clinical experience, but they do have a strong asset going for them: intimate knowledge of their bodies and access to information only they can provide. The rise of wearable technologies over the past decade has only increased patients ability to quantify their experiences, health and otherwise. Diet, exercise, daily habits, stress levels, family life, physical environment all contribute to an overall picture of health. Yet too often, clinicians only see a slice of their patients health picture – the picture that is presented during office visits. The increased importance of tracking lifestyle data has clinicians and technologists asking themselves, How do we unlock more information in order to make better decisions and deliver better care?

The field is called Patient Engagement. And while the industry has mutually agreed upon it’s critical importance, the question remains as to what it looks like.Continue reading…

Health for coins, not dollars ;) – The “not so serious” Mapping of Healthcare Cryptocurrencies

At this years’ SXSW it was all about blockchain and cryptocurrencies, but it was like that at HIMSS, JPM, CES, etc. as well. Since we wrote already about the first of the two buzzwords – blockchain as a trend in Healthcare, we decided to tackle the idea of cryptocurrencies in healthcare. First, we checked around the office and found out that several devs have been in a couple of Telegram chat rooms as they tried to buy “health coins” in a presale (ICO – initial Coin Offering; Pre-ICO).

Will you be buying your next health plan with ethereum? Or is the new health coin going to solve the problem of fragmented healthcare records?

Continue reading…

Apple, Cerner, Microsoft, and Salesforce

… all rumored to be in the mix to acquire athenahealth.

Nope.

Why not?

a) Apple doesn’t do “verticals.” It’s that easy. Apple sells products that anyone could buy. A teacher, a doctor, my mom. Sure – they have sold high-end workstations that video editors can use, but so could a hobbyist filmmaker. Likelihood of Apple buying athenahealth? ~ .01%

b) Cerner? Nah. While (yes) they have an aging client-server ambulatory EHR that needs to be replaced by a multi-tenant SaaS product (like the one athenahealth cas built), they have too much on their plate right now with DoD and VA and the (incomplete) integration of Siemens customers. Likelihood of Cerner buying athenahealth?  ~ 1%

c) Microsoft. Like Apple, it’s uncommon for MSFT to go “vertical.” They have tried it. (Who remembers the Health Solutions Group?) But the tension between a strong product-focused company that meets the needs of many market segments, and a company that deeply understands the business problems of health (and health care) is too great. The driving force of MSFT, like Apple, is to sell infrastructure to care delivery organizations. Owning a product that competes with their key channel partners would alienate the partners – driving them to AMZN, GOOG and APPL. Likelihood of Microsoft buying athenahealth?  ~ 2%

d) Salesforce. I’d love to see this. But it’s still unlikely. athenahealth has built a product, and they (now) have defined a path to pivot the product into a platform. This is the right thing to do. Salesforce “gets” platform better than everyone (aside from, perhaps, Amazon). But Salesforce has struggled with health care. They’ve declared times in recent years that they are “in” to really disrupt health care, and with the evolution of Health Cloud, and their acquisition of MuleSoft, they have clearly made some investments here, but the EHR is not the “ERP of healthcare” as they think it is. (Salesforce’s success in other markets has been that they dovetail with – rather than replace – the ERP systems to create value and improve efficiencies.) The way that Salesforce interacts with the market is unfamiliar (and uncomfortable) to most care delivery organizations. So if Salesforce “gets” platform, and athenahealth wants to be a platform when it matures, could these two combine? It’s the most likely of the three, but I still see the cultures of the two companies (I know them both well) as very different, and not quite compatible. Likelihood of Salesforce buying athenahealth?  ~ 10%

e) IBM. yup. I forgot that one. Many recent acquisitions. This would fit. I don’t think it would work very well, but it could happen. ~6%

Others?Continue reading…

Mudit Garg, Qventus on the $30m raise

Another day, another $30m round in health tech. On Monday Qventus raised that from Bessemer Partners, with Mayfield, Norwest and NY Presbyterian kicking in too. That brings their total to $43m in so far–not bad for a 75 person company that is in the somewhat obscure space of using AI to improve hospital operations. Qventus sucks in data and delivers operational suggestions to front line managers. Of course given that somewhere between $1-1.5 trillion goes through America’s hospitals each year, there’s huge potential for saving money. And given that most hospitals are being paid fixed cost per case, anything that can be done to improve throughput and increase productivity drops to the bottom line and is thus likely to meet interested buyers. I talked to CEO Mudit Garg about the problem, his company’s solution and what they were going to do next.

The Time is Now to Develop and Implement a National Health Data Strategy

The 19th century was about the Industrial Revolution. The 20th century, the Digital Revolution. As we march closer to the third decade of the 21st century, it is becoming clearer that this century’s revolution will be the Data Revolution. After all, companies are monetizing it, countries are weaponizing it and people are producing it.

In the medical space, this has fostered conflicting aims. The promise afforded by collecting and analyzing digital health data for insights into population health and personalized medicine is tempered by haziness on who owns and leverages that data.

But even as government actors struggle with the question of how to regulate data, technological progress marches on. Given the dizzying array of technological products claiming medical benefits hitting the marketplace, regulatory agencies have had to contemplate, and take, drastic steps to keep up. For instance, in the past two years the FDA has taken the following steps:

  • In July 2016, the FDA clarified what constituted a “low-risk” device such as fitness trackers or mobile apps tracking dietary activity.
  • In June 2017, new FDA Commissioner Scott Gottlieb outlined his vision for a more streamlined process for digital technologies which moves from a “case-by-case” approach to one that allows developers apply consistent safety standards to innovation.
  • Just a month later, the FDA announced the pilot for a digital health pre-certification program for individual companies which allows those firms that demonstrate a “culture of quality and organizational excellence” and the need for minimal regulation to introduce products to be marketed as new digital health tools with less information communicated to the FDA, sometimes with no “premarket submission at all”.
  • By September 2017, nine companies, including tech heavyweights Apple, Samsung and Alphabet-backed Verily, had been selected for the pre-cert process.
  • On February 13, 2018, the FDA further specified that low-risk products would be evaluated by looking at the firm’s practices rather than the product itself and announced its intent to create a new Center of Excellence on Digital Health which would be tasked with establishing a new regulatory paradigm, evaluating and recognizing third-party certifiers and hosting a new cybersecurity unit to complement new advances.

With this flurry of activity, the FDA is clearly moving toward a principles-oriented and firm-based approach to regulating digital technologies. This means moving away from certifying medtech products to the producers.

Continue reading…

The Peril of Online Physician Reviews

You may have heard that before you pick a doctor you are supposed to look them up online and see what other people have to say about them before you set up an appointment.

In the Age of Amazon this makes sense. Why wouldn’t you?

Allow me to give you a little insider information.  While they may well be a good idea in theory, Yelp.com and other online physician review sites have evolved in recent years to become the bane of my and fellow doctors existence. 

This past summer, Physicians Working Together, a non-partisan physician organization, started a petition on Change.org requesting Yelp remove online reviews of doctors.  To date, more than 30,000 physicians have signed it but I doubt Yelp will pay much attention.

Recently, the highest-level court in Germany ruled Jameda, an online physician rating site, must remove the name of a disgruntled physician.   A dermatologist from Cologne filed the case in the Federal Justice Court demanding Jameda remove her name due to the fact the anonymous nature of the rating site inspires the public to leave spiteful, vindictive comments.  Interestingly enough, in 2014, a gynecologist asked to be removed from Jameda, however the Court ruled the right of patients to be “well informed” about their doctor took precedence over freedoms of the physician.

What is the value of rating physicians online?  Are consumers becoming “well-informed?”

Continue reading…

Apple’s EHR: Why Health Records on Your iPhone is Just the Beginning

Americans on average will visit a care provider about 300 times over the course of their lives. That’s hundreds of blood pressure readings, numerous diagnoses, and hundreds of entries into a patient’s medical record—and that’s potentially with dozens of different doctors. So it’s understandable, inevitable even, that patients would struggle to keep every provider up-to-date on their medical history.

This issue is compounded by much of our healthcare information being fragmented among multiple, incompatible health systems’ electronic health records. The majority of these systems store and exchange health information in unique, often proprietary ways—and thus don’t effectively talk with one another.

Fortunately, recent news from Apple points to a reprieve for patients struggling to keep all of their providers up-to-date. Apple has teamed with roughly a dozen hospitals across the country, including the likes of Geisinger Health, Johns Hopkins Medicine, and Cedars-Sinai Medical Center, to make patient’s medical history available to them on their phone. Patients can bring their phone with them to participating health systems and provide caregivers with an up-to-date medical history.

Empowering patients with the ability to carry their health records on their phone is great, and will surely help them overcome the issue of fragmented healthcare records. Yet the underlying standardization of how healthcare data is exchanged that has made this possible is the real feat. In fact, this standardization may potentially pave the way for innovation and rapid expansion of the health information technology (HIT) industry.

Continue reading…

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