The Health Care Blog – Page 235 – Everything you always wanted to know about the Health Care system. But were afraid to ask.

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FDA Mobile Medical Applications NPRM

Dec 1, 2018

By JOHN HALAMKA, MD

Many have asked me for an analysis of the new FDA Mobile Medical Applications NPRM.

The FDA will not seek to regulate mobile medical apps that perform the functionality of an electronic health record system or personal health record system. However, the FDA defined a small subset of mobile medical apps that may impact the functionality of currently regulated medical devices that will require oversight. Here’s a thoughtful analysis by Bradley Merrill Thompson of Epstein Becker Green, which he has given me permission to post:

“Today, FDA published the long-anticipated draft guidance on the regulation of mobile apps—more specifically, what the agency calls “mobile medical apps”. This draft reflects significant efforts by FDA in a fairly short amount of time, and we applaud that work. Much of the framework of the FDA guidance is consistent with the work the mHealth Regulatory Coalition (MRC) published on its website earlier this year (www.mhealthregulatorycoalition.org). While FDA has done a good job getting the ball rolling, there are a number of areas that require further work. We all (including FDA) recognize that this draft guidance is certainly not the end of the story.

The regulatory oversight recommended in today’s draft guidance applies only to a small subset of mobile apps, which FDA defines as any software application that runs on an off-the-shelf, handheld computing platform as well as web-based software designed for mobile platforms. To be regulated, as a first step the app would have to first meet the definition of a medical device and then as a second step either (1) be used as an accessory to another regulated device or (2) “transform” the handheld platform into a device, such as by using the platform’s display screens or built-in sensors.

How Not to Create an HIE

Dec 1, 2018

By JOHN MOORE

Sometimes, the job of an analyst can be so frustrating.

A core part of the Chilmark Research charter is to educate healthcare stakeholders on critical trends in the marketplace that will lead to better, more successful adoption of IT and subsequently improve the health of the nation (if not the world). There are a couple of things we have learned along the way:

1) Little if anything gets adopted at scale in the healthcare sector (and for that matter virtually any other market) if it does not provide value to the end user that exceeds risk. That risk could be privacy, it could be a productivity hit, it may be liability; plenty of risk in healthcare, both perceived and real to trip up an IT initiative.

Rhetoric Ahead of Reality: Doctor Ratings Not Useful Yet

Dec 1, 2018

By JESSIE GRUMAN

“Most physicians are competent and able to take care of most of the problems patients present with. The standards for getting into medical school are high and for getting out are higher. I think this call for patients to become experts in picking their doctors is overstated.” – David Rovner, MD, Professor Emeritus, Michigan State University

Most? What does “most” mean? Can most doctors treat me for the flu? How about pancreatic cancer? Must I conduct the same type of research to choose a doctor to set my broken arm that I do to find one to treat my mom’s congestive heart failure? Is the same level and type of research necessary to find a good surgeon as for a primary care clinician?

There are no easy answers to these questions. The steady stream of media messages and articlesurging us to thoroughly check out any new physician we might consult stand in stark contrast to my colleague David’s opinion. The release of the latest “Top Doctors” from the US News and World Report’s“Best” series is surely a sign that, in a declining print media market, lists of superlatives still boost magazine sales. But reports like these do little to help us understand what is at stake in doing so or to figure out under what circumstances it is important. Rather, they assume that we are sufficiently anxious or cautious to dive into conducting research prior to making any and all doctor choices.

Practical Collaborative Document Writing for Patient Communities

Dec 1, 2018

By FRED TROTTER

I have a lot of experience with collaborative document writing, and now, in my role with Cautious Patient Foundation, I have been providing technical help to several patient communities. I helped write the security standards for the NWHIN Direct project and I am currently working with the e-patient/QS community to create a document detailing Doctor friendly Quants and Quant friendly Doctors.

My advice is pretty simple:

Use a forum, either a facebook thread or a mailing list to determine who the primary authors should be, and what the general content of the document should be.Continue reading…

The Usefulness and Uselessness of Electronic Medical Records

Dec 1, 2018

By RICHARD REECE, MD

Nothing is so useless as a general maxim.

Lord MacCaulay (1800-1859), On Machiavelli (1827)

I dare say that I have worked off my fundamental formula on you that the chief end of man is to frame general propositions and that no general proposition is worth a damn.

O.W Holmes, Jr. (1809-1904), as quoted in The Practical Cogitator, 1962

The general maxim and general proposition behind the rationale of a national interoperative electronic medical record system in every physician’s office is that you can never get too much information and that government can use digital data to cut costs and improve care.

The Problem

Sounds good, doesn’t it? The problem is that so far, after nearly a decade of advancing this maxim and proposition, perhaps 80% of physicians in independent practice aren’t buying. And this, in face of the reality, that government has proposing spending $27 billion to get EHRs off the ground. And beginning this year, CMS will start offering as much as $44,000 per physician over a staggered five years if physicians make “meaningful” use of “certified” medical records. Many doctors regard such rhetoric as empty talk that will accompanied by unreasonable bureaucratic requirements, as surely as dawn following night.

Why no “buy-in” among doctors? Why have two national IT coordinators appointed by Obama, David Brailer,ND, in 2005 and David Blumenthal, MD, in 2011, resigned in frustration over the failure to persuade doctors that gathering electronic data and measuring care is a good thing? If universal EHRs are such a good thing, why have physicians and hospitals not raced to embrace EHRs?

As Steve Lohr of the New York Times, a leading thinker in health care innovation, says in yesterday’s Times (“Seeing Promise and Peril in Digital Records,”

“What is beyond doubt is that the promise of digital records will be unfulfilled if doctors refuse to adopt them, because they regard the technology as cumbersome, time consuming, and possibly dangerous.”

To date, most doctors, except for enthusiastic early adopters, IT nerds, and those in large organizations, have found EHRs “useless” in their daily work. EHRs cost excess money, show little return on investment, change the very nature of practice, slow productivity, tell no narrative tales, cause conflicts among staff and colleagues, require extensive record keeping, are subject to hacking, and, more often than not, are useless as a tool for communicating to colleagues, hospitals, and other doctors outside your practice.

When the government establishes “usability standards” that work, maybe doctors will come on board the electronic train. Until then, says Dr. Edward H. Shortliffe , a professor at the University of Texas Health Science Center in Houston, “Usability is going to be the single greatest impediment to physician acceptance. “

If EHRs are not made more useful and soon, universal digital records may turn out to be a giant boondoggle rather than a scientific bonanza.

Richard L. Reece, MD, is pathologist, editor, author, speaker, innovator, and believer in abilities of practicing doctors and their patients to control and improve their health destinies through innovation. He is author of eleven books. Dr. Reece posts frequently at his blog, Medinnovation.

Hospital-Physician Mergers: All Is Not Well

Dec 1, 2018

By JAAN SIDOROV, MD

The Disease Management Care Blog, believing that the ultimate end game will be an historic insurer-physician alignment, checked out an “Issue Brief” on the Rising Employment of Physicians, courtesy of the Center for Studying Health Center Change (hat-tip to the folks at KHN). The authors interviewed hospital, health plan and other provider executives from 12 representative locations around the country and came away with some telling impressions on what’s happening in the hospital market place.

The authors didn’t find much in the way of insurer-physician alliances, but they sure found evidence of increasing employment of physicians by hospitals. Why? For the docs, it’s a perfect storm of declining reimbursement, growing overhead, increasing insurer hassles, the cost of implementing an EHR and the high premium for liability (malpractice) insurance. In addition, younger physicians are attracted to the prospect of a better work-life balance that comes with steady employment. For the hospitals, it’s the opportunity consolidate market-power, maintain a referral base and do away with the revenue-stealing physicians’ in-office and surgi-center procedures.

Yet, while economics are driving docs into the arms of the hospitals, the authors cautioned that all is not well when it comes to 1) coordination of care/quality, 2) costs and 3) access to care.

HIE Market Snippets

Dec 1, 2018

By JOHN MOORE

In January, we released our HIE Market Report: Analysis & Trends which was extremely well-received. Sales have exceeded our rather optimistic projections – great for us. But what we are most proud of and honestly what keeps us going is that others are also gaining value from this report, especially those looking to purchase an HIE solution. As one large healthcare organization recently told us:

Your report has been invaluable in not only our vendor assessment process, but how our organization needs to think about our long-term HIE strategy.

We have also heard on numerous occasions the need to update the report as the market is changing so quickly and indeed it has. Several HIE vendors have been acquired, others have withdrawn from the market and there continues to be an influx of new entrants hoping to capitalize on what remains an immature market.

There are also a number of underlying trends that have disrupted the market to varying degrees. Thus, we have begun putting together our research plan for an update of the HIE report. As part of that process we have been contacting and interviewing those who purchased the first report to get their feedback on what they would like to see in the next edition. Several interviews have been conducted so far and we even had a briefing with one HIE vendor that we had given up for dead, but no, looks they are very much alive and may (emphasis on may) become a strong player in the future provided their new parent invests in them at the level required to build market share.

Why Medical Specialists Should Want to End the Reign of the RUC

Dec 1, 2018

By PAUL M. FISCHER, MD

The old doctors know. The practice of medicine has changed in a very basic way over the last 20 years. Physician relationships have lost their civility and have been replaced by a level of tension that takes the fun out of collegial interactions. I remember my first year of family medicine as the only doctor in Weeping Water, Nebraska. My personal medical community had gone from an entire medical school campus with limitless lectures and many physicians to share in “interesting cases” to an occasional phone call with a consultant in Omaha. These contacts became my primary source for medical education and updates for Weeping Water’s health care. The phone calls were collegial, respectful, and focused on what was best for my patients.

What happened?

The RUC is the secretive committee of the AMA that has been CMS’s primary source of physician payment data over the past 20 years. It has elaborately articulated the complexity of medical procedures but ignores and confuses the cognitive work involved in patient care – collapsing it into a few evaluation and management codes. As a result, many medical specialties have found that their financial success is tied primarily to doing things TO patients, rather than caring FOR patients.

The RUC has shifted these physicians’ attention away from the hard work of knowing patients over time and fine-tuning their treatments based on subtle changes discovered by history and physical toward focusing on which procedure can be done to a patient and legitimized to an insurance company. Let the “primary” do that other stuff.

The Pace of Change

Dec 1, 2018

By JOHN HALAMKA, MD

My travels in Japan included lectures in Tokyo and Kyoto, sharing lessons learned from the US health information technology national efforts. I highlighted that the Office of the National Coordinator has to balance the desire for innovation with a pace of change that vendors and clinicians can tolerate.

This led me to think about the pace of change that CIOs are experiencing right now. The IT innovations of the past few years have been dizzying and the cycle between the peak of hype to the trough of obsolescence is now measured in months, not years.

Some examples of rise and fall

1. Blackberry – I was one of the earliest adopters of Blackberry technology, using a small pager-like device for short text messages. As each new model was announced, I welcomed the innovations – the evolution from thumbwheel to joystick to track pad, larger color screens, cameras, video features, and voice memo recording. However, in 2011, my mobile device needs have outpaced Blackberry’s engineering. I now need a full featured web browser, a book reader, the ability to zoom/drag via touch screen, and a robust App Store. Until 2010, Blackberry seemed to be unstoppable in the corporate messaging world. Now it is laying of 2500 people as the iPhone and Android devices rapidly replace Blackberries in consumer and business settings. They tried very hard to introduce new devices such as the Storm, the Playbook, and the Torch, but came up short as customer expectations exceed their pace of innovation.

Is There an Independent Unbiased Expert in the House?

Dec 1, 2018

By SHANNON BROWNLEE

Last week, U.S. Food and Drug Administration Commissioner Margaret Hamburg told the advocacy group Public Citizen that the FDA may loosen conflict-of-interest rules for experts who serve on the agency’s advisory panels. These panels wield considerable power when it comes to FDA decisions about approving drugs and medical devices, and for pulling them off the market when evidence surfaces that they may cause patients harm.

Why loosen the rules? Commissioner Hamburg said the agency is having trouble finding experts to fill its advisory panel slots. In other words, anybody expert enough to be on an FDA panel undoubtedly has a conflict.

Or maybe the FDA just isn’t looking very hard. In 2008, Jeanne Lenzer — an independent journalist — and I created a list of more than 100 experts in fields ranging from epidemiology to neurology to emergency medicine, every one of them independent from industry conflicts of interest. We made the list available to our fellow journalists at the website, Healthnewsreview.org, a site that grades health stories. Dozens of journalists from top news outlets, including the New York Times,Bloomberg, and the Wall Street Journal, have requested the list, and used it to find sources for their stories — or at least we hope they have.