With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”
While this sounds nice, how, exactly, does one become a “prescribed patient?” Once a doctor “prescribes” such a device, what are his responsibilities? Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?
At this point, no one knows. We are entering into new, uncharted medicolegal territory.
But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device. But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.
This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them. So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:
Continue reading “When Patients Can Obtain Their Own EKG”
Filed Under: THCB
Tagged: AliveCor, Dave Alpert, Dr. Wes, EKG, iPhone, Medical Devices, Workflow
Feb 16, 2013
Somewhere between the 20th century Bank ATM and the 25th century Tricorder, lays the EMR that we should have today.
Somewhere between the government-designed Meaningful Use EMR and the Holographic doctor in Star Trek, there should be a long stretch of disposable trial-and-error cycles of technology, changing and morphing from good to better to magical. For this to happen, we must release the EMR from its balls and chains. We must release the EMR from its life sentence in the salt mines of reimbursement, and understand that EMRs cannot, and will not, and should not, be held responsible for fixing the financial and physical health of the entire nation. In other words, lighten up folks …
A patient’s medical record contains all sorts of things, most of which diminish in importance as time goes by. Roughly speaking, a medical record contains quantifiable data (numbers), Boolean data (positive/negative), images (sometimes), and lots of plain, and not so plain, English (in the US).
The proliferation of prose and medical abbreviations in the medical record has been attacked a very long time ago by the World Health Organization (WHO), which gave us the International Classification of Disease (fondly known as ICD), attaching a code to each disease. With roots in the 19th century and with explicit rationale of facilitating international statistical research and public health, the codification of disease introduced the concept that caring for an individual patient should also be viewed as a global learning experience for humanity at large. Medicine was always a personal service, but medicine was also a science, and as long as those growing the science were not far removed from those delivering the service, both could symbiotically coexist.
Continue reading “Set My People Free”
Filed Under: THCB
Tagged: AMA, Data, EHR, HIT, ICD, Interoperability, Margalit Gur-Arie, Meaningful Use, patient health records, Twitter, WHO, Workflow
Jan 21, 2013
Everyone, including this blog writer, has been touting the virtues of the vast troves of data already or soon to be available in the electronic health record (EHR), which will usher in the learning healthcare system [1, 2]. There is sometimes unbridled enthusiasm that the data captured in clinical systems, perhaps combined with research data such as gene sequencing, will effortlessly provide us knowledge of what works in healthcare and how new treatments can be developed [3, 4]. The data is unstructured? No problem, just apply natural language processing .
I honestly share in this enthusiasm, but I also realize that it needs to be tempered, or at least given a dose of reality. In particular, we must remember that our great data analytics and algorithms will only get us so far. If we have poor underlying data, the analyses may end up misleading us. We must be careful for problems of data incompleteness and incorrectness.
There are all sorts of reasons for inadequate data in EHR systems. Probably the main one is that those who enter data, i.e., physicians and other clinicians, are usually doing so for reasons other than data analysis. I have often said that clinical documentation can be what stands between a busy clinician and going home for dinner, i.e., he or she has to finish charting before ending the work day.
I also know of many clinicians whose enthusiasm for entering correct and complete data is tempered by their view of the entry of it as a data blackhole. That is, they enter data in but never derive out its benefits. I like to think that most clinicians would relish the opportunity to look at aggregate views of their patients in their practices and/or be able to identify patients who are outliers in one measure or another. Yet a common complaint I hear from clinicians is that data capture priorities are more driven by the hospital or clinic trying to maximize their reimbursement than to aid clinicians in providing better patient care.
Continue reading “The Data Entry Paradox”
Filed Under: THCB
Tagged: Data Entry, documentation, EHR, Informatics, Usability, William Hersh, Workflow
Oct 4, 2012
In my recent post Work Induced Attention Deficit Disorder, several commenters asked how I stay focused and productive, speculating that I leverage my limited need for sleep.
Although having a 20 hour day helps, the real secret is that I end each day with an empty inbox. I have no paper in my office. I do not keep files other than those that are required for compliance purposes.
The end result is that for every document I’m asked to read, every report I’m ask to write, and every situation I’m asked to management, I only handle the materials once.
What does this mean?
In a typical week, I’m asked to review 4 or 5 articles for journals. Rather than leaving them to be read at some later time or reading them then deferring the review, I read and review them the day they are assigned. This enables me to read them once and write the review very efficiently since all the facts are fresh in my mind.
Continue reading “Only Handle It Once (OHIO)”
Filed Under: THCB
Tagged: administrative work, office management, Workflow
Jan 18, 2012
Why are doctors so slow in implementing electronic health records (EHRs)?
The government has been trying to get doctors to use these systems for some time, but many physicians remain skeptical. In 2004, the Bush administration issued an executive order calling for a universal “interoperable health information” infrastructure and electronic health records for all Americans within 10 years.
And yet, in 2011, only a fraction of doctors use electronic patient records.
In an effort to change that, the Obama economic stimulus plan promised $27 billion in subsidies for health IT, including payments to doctors of $44,000 to $64,000 over five years if only they would use EHRs. The health IT industry has gathered at this multibillion-dollar trough, but it hasn’t had much more luck getting physicians to change their ways.
What is wrong with doctors that they cannot be persuaded to adopt these wondrous information systems? Everybody knows, after all, that the Internet and mobile apps, powered by Microsoft, Google, and Apple and spread by Facebook, Twitter, YouTube, and the iPhone and iPod, will improve care and cut costs by connecting everybody in real time and empowering health-care consumers.
Continue reading “Why Doctors Don’t Like Electronic Health Records”
Filed Under: Physicians
Tagged: EHR, EHR resistance, Physicians, Richard Reece, Workflow
Oct 7, 2011
Yesterday, Chilmark Research participated in the CRG conference, Driving Change Through Managed Care IT from Provider Payments to Quality, which was held in New York City. Despite having a title that no one will be able to remember, the overall theme of the event and presentations therein gave one a bird’s eye view into what payers are thinking as we march forward with healthcare reform and the digitization of the healthcare sector.
A common theme that repeated itself numerous times over the course of the day was the lack of business process maturity in the healthcare sector. Meg McCarthy, EVP of Innovation at Aetna was the first to make this statement citing this issue as arguably the number one challenge for this industry sector to overcome. (McCarthy provided some interesting details on the Medicity acquisition but we’ll save that for a later date.)
Later that day, Jessica Zabbo, Provider Technology Supervisor at RI-BCBS gave a very detailed presentation on her company’s experiences working with providers on the adoption and use of EHRs. Over the last several years RI-BCBS has done a couple of small pilots. In both cases a defining parameter of success was business process maturity. For example, the company did a Patient Centered Medical Home (PCMH) pilot that coupled pay for performance metrics (P4P) with EHR use. Basically P4P measurements were to be recorded and reported through the EHR. One of the key lessons learned was that P4P program success was highly dependent on the EHR being fully implemented and physicians comfortable with its use (process maturity). But in a Catch-22, to successfully incorporate P4P metrics into the EHR requires a very deep understanding of practice focus and workflow. Without that understanding, failure of the P4P program is almost certain. Continue reading “Remember: Technology is but a Tool”
Filed Under: THCB
Tagged: EHR, John Moore, Payers, Process, Workflow
Mar 30, 2011
It has become politically incorrect to refer to EHRs as products. Instead, EHRs are now “technologies” as evident in all ONC and CMS published rules and regulations. This subtle change in terminology was intended to encourage, yes you guessed it, Innovation. It was supposed to signal an open market for alternatives to existing EHR products in the form of modular approaches, open platforms, mobile applications and web-based software-as-a-service. Naturally, the industry is obliging and all efforts now are geared towards creating stuff that runs on iPads, preferably “cloud” based and with minimal utility. The new stuff looks very cool and promises to become even cooler, so what’s the problem?
The problem is that these new things do not solve any problems. Traditional product innovation concentrated on identifying problems, designing solutions and then selecting technologies that were capable of enabling those solutions. New technologies were usually born out of the necessity to solve a burning problem and those with enough applicability to larger markets became blockbusters. Every frying-pan today sports technology first invented in the process of creating refrigerants and later used for nuclear destruction (Teflon). Every large enterprise embarking on cost cutting, new markets acquisition, or general improvements, should know all too well that selecting a “cool” technology first, and then attempting to find a good use for it, is recipe for failure.
Continue reading “EHR Product Management”
Filed Under: Electronic Health Records, Margalit Gur-Arie
Tagged: EHR, Physicians, THCB Marketplace, The DC, Workflow
Jan 24, 2011