On ONC's "Proposed Establishment of Certification Programs for Health Information Technology"

The Office of the National Coordinator for Health Information Technology of HHS (the Department of Health and Human Services) has issued a proposed rule "RIN 0991-AB59 Proposed Establishment of Certification Programs for Health Information Technology." The proposed rule is available in PDF at this link and more information is available from ONC itself at this link.

I have written a response to the proposed rule that will be sent as a public comment to the Federal eRulemaking Portal (http://www.regulations.gov/search/Regs/home.html).

I reproduce my response below:

Mar. 9, 2010

Re: RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology" (http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf):

Dear HHS/ONC:

I believe the deadlines driving establishment of a certification program for health IT as proposed in RIN 0991-AB59, as well as for achieving “meaningful use of healthcare IT” and for onset of medicare penalties for “non adopters”, will result in diffusion of healthcare IT that, in the words of the Jan. 2009 National Research Council report on health IT “will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause” (http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572).

I believe the national health IT system that will result will be injurious to patients at an unacceptably high level as well.

I am a physician and Yale-trained medical informatician and have been writing about the challenges of healthcare IT since the late 1990’s. My bio is at http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm and my teaching site on HIT difficulties is at http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/ . I also write on Medical Informatics and HIT for the Healthcare Renewal blog of the Foundation for Integrity and Responsibility in Medicine (FIRM), a 501(c)(3) policy think tank, at http://hcrenewal.blogspot.com.

I have labored over the past decade to steer health IT efforts away from known and predictable paths of difficulty, failure and adverse consequences based on medical science, the science of Medical Informatics, ethical considerations, and the experience of other nations with HIT. I am writing to you to express serious concerns about ONC’s HIT Certification Program NPRM (http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf).

In effect, the NPRM calls for healthcare IT to receive a special governmental accommodation, apparently in part due to politically-decided, and certainly non-scientifically derived timelines. The special accommodations are in the areas of certification, post-market surveillance and inadequate use of existing regulatory expertise over safety-critical IT by agencies with specific domain expertise in that undertaking, thus “reinventing the wheel.”

(On the non-scientific nature of the timelines, see, for example, “Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless?”, Ford et. al, JAMIA 2006 13: 106-112, http://jamia.bmj.com/content/13/1/106.full.pdf.) [note: also see addendum below - ed.]

First and foremost, the term “safety” itself appears in the RIN 0991-AB59 proposal text only four times, and not in the context of strong provisions to safeguard patients from adverse consequences of healthcare IT. This in and of itself is, quite frankly, of great concern, especially in the context of known HIT safety issues.

For instance, FDA’s testimony at ONC’s HIT Policy Committee Adoption/Certification Workgroup meeting on HIT safety (Feb. 25, 2010) itself revealed known patient injuries and deaths related to healthcare IT difficulties.

Even more importantly than the fact of these HIT-related adverse events, however, was the revelation that the true extent of these adverse events is unknown. As FDA’s Jeffrey Shuren, MD, JD expressed it, the data he provided is likely “just the tip of the iceberg.” This supports the contention that the technology is still in an experimental phase, rather than being tried and true.

A growing body of literature supports that view (e.g., see “2009 a pivotal year in HIT” at http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009).

It also seems that unscientifically arrived at timelines (i.e., the politically-decided timelines for HIT adoption and achievement of “meaningful use”) that ignore the experimental nature of healthcare IT – that it is not yet “ready for prime time” in a national rollout - are promoting a rush to a superficial certification and surveillance process.

This is alien to the science, culture and ethical obligations of medicine and its practitioners.

The latter process, surveillance, is apparently intended to merely surveil continued conformance of HIT to agreed-upon standards, not patient safety as in the pharmaceutical and tangible-medical device postmarketing surveillance process.

I consider HIT a medical device that is virtual in nature, but a medical device nonetheless, a position the EU is steering towards. See "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (available in English translation in PDF at http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf).

While I believe the NPRM proposal is a step up from the former certification roles envisioned by CCHIT and HIMSS, the proposal still lacks the rigor I have called for in many of my writings about HIT over the past decade.

On the formation of new “ONC-Approved Accreditors” (ONC-AA’s) for certification, this is a special accommodation for the HIT industry that appears to inexplicably place that sector in a favored position compared to the pharmaceutical, medical device and other industries that utilize safety-critical IT.

The FDA, for example, has significant expertise in validating and regulating IT in the pharmaceutical and medical device industries, including that used in clinical trials which bear similarities to HIT used in the delivery sector. For instance, see "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf.

This document opens with the statement:

• This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.

As yet another example, NASA has published a document “Certification Processes for Safety-Critical and Mission Critical Aerospace Software” (http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf). This document begins:

• Since safety-critical aerospace software is prevalent and important to human life, what is the rationale behind certification of such software? In other words, how do engineers know when a new software product works properly and is safe to fly? In the United States, software must undergo a certification process described in various standards by various regulatory bodies including NASA and the Requirements and Technical Concepts for Aviation (RTCA) which is enforced by the Federal Aviation Administration (FAA).

• How do researchers know which standards apply to their software? Each NASA center and the FAA have unique certification processes for different types of software. For example, there are special processes for the Space Shuttle and different processes for the Space Station. Any software that flies onboard an aircraft in FAA airspace must adhere to special FAA certification processes. There are also different processes depending upon whether the software is safety- or mission-critical or falls into another category. The UK and Europe have similar certification processes.

HHS should not be creating new, potentially (likely?) amateur organizations and bureaucracies overseeing these new virtual medical devices that will have variable (or no) experience in software validation, certification, regulation, postmarketing safety surveillance, etc. Rather, HHS should be leveraging existing governmental expertise in certifying, validating and regulating mission critical IT.

Further, what is to protect these new bureaucracies from being staffed by those with conflicts of interest with the industry whose products they are purported to certify and surveil? At the very least, existing federal agencies have policies on such conflicts.

Of note, we have a prime example of what can occur due to politically-mediated rushing of healthcare IT – that of the UK’s National Programme for Healthcare IT (NPfIT).

British PM Tony Blair repeatedly sought to shorten the timetable for the NHS national IT programme in a move that would have brought results for patients in time for a general election in 2005 (see http://www.computerweekly.com/Articles/2008/02/18/229447/secret-downing-street-papers-reveal-tony-blair-rushed-nhs.htm.) The result was predictable. A summary of the UK’s House of Commons, Public Accounts Committee’s 2009 report on near-disastrous problems in their £12.7 billion national EMR program is at http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm. From that summary:

• “Recent progress in deploying the new care records systems has been very disappointing …The Programme is not providing value for money at present because there have been few successful deployments of the Millennium system and none of Lorenzo in any Acute Trust … Despite our previous recommendation, the estimate of £3.6 billion for the Programme's local costs remains unreliable … Little clinical functionality has been deployed to date, with the result that the expectations of clinical staff have not been met … Patients and doctors have understandable concerns about data security."

And so forth.

Further, from the UK National Audit Office Executive Summary of 16 May 2008 (http://www.nao.org.uk/publications/0708/the_national_programme_for_it.aspx):

• At the outset of the Programme, the aim was for implementation of the systems to be complete and for every patient to have an electronic care record by 2010, although the timetable from 2006 was described as tentative. While some parts of the Programme are complete or well advanced, the original timescales for the Care Records Service – one of the key components of the Programme – have not been met.

We ignore the UK experience at our peril, an experience in a medical environment smaller and far more government-controlled than our own.

Finally, I call attention below to the actual ONC NPRM passages from which my concerns arise on “time constraints” leading to a rushed and superficial certification program (which I believe is frankly cavalier and irresponsible considering the stakes involved).

I believe that a rushed National Program for HIT in the United States will suffer the same fate as the aforementioned National Programme for IT in the UK, and perhaps even a worse fate as the UK’s socialized medicine system is certainly a smaller, more homogeneous and more controllable testbed environment for experimenting with HIT.

In summary, I believe the current approach to Healthcare IT certification is inadequate, in large part due to time constraints set upon the effort that are themselves artificially rushed and inadequate. I believe much more significant leveraging of existing biomedical and mission critical IT certification/validation expertise is essential, and that patient safety, not continuing adherence to existing standards should be a primary concern of post-implementation surveillance.

Thank you for considering these views.

I believe rushing health IT, and burying our heads in the sand about the predictable and demonstrated repercussions of doing so as outlined above and on this and other websites, is a very bad idea.

Making like an ostrich on national-scale healthcare IT is a very bad idea.

I have written about FDA myself and not always in complementary terms (e.g., here, here), but my concern is that the creation of multiple new potentially amateur organizations does not bode well for HIT, either.

The key to successful HIT certification, validation and patient safety is 1) leveraging the needed expertise but 2) without industry conflict of interest and 3) without the pathologies of the HIT 'ecosystem' and culture spoiling the environment (see my aforementioned website on HIT difficulties for more on that topic, as well as the HIT ecosystem essay at that site).

Perhaps a new federal HHS subunit is a potential solution - a Clinical Computing Administration (CCA) with regulatory teeth.

The oversight of hundreds of billions of dollars of technology and the patients the technology itself affects calls for a quite serious approach to these issues, in my view.

-- SS

March 9, 2010 Addendum:

On rushing national health IT programs - unknown to me when I wrote the post above, this article just appeared in the British Press:

Patients' medical records go online without consent
Telegraph.co.UK
By Kate Devlin, Medical Correspondent
Published: 10:20PM GMT 09 Mar 2010

Those who do not wish to have their details on the £11 billion computer system are supposed to be able to opt out by informing health authorities.

But doctors have accused the Government of rushing the project through, meaning that patients have had their details uploaded to the database before they have had a chance to object.

... Hamish Meldrum, [the British Medical Association] chairman, writes: "The breakneck speed with which this programme is being implemented is of huge concern ... "If the process continues to be rushed, not only will the rights of patients be damaged, but the limited confidence of the public and the medical profession in NHS IT will be further eroded."

... Norman Lamb, the Liberal Democrat health spokesman, said: "The Government needs to end its obsession with massive central databases. "The NHS IT scheme has been a disastrous waste of money and the national programme should be abandoned."

Read the whole thing.

-- SS