These themes revolve around the consideration of healthcare information systems (increasingly used to mediate many aspects of medical care delivery) as medical devices requiring regulation by transparent and impartial authorities - i.e., without conflicts of interest; the importance of regulation due to the adverse consequences caused by ill designed and/or poorly implemented HIT; the need for validation and postmarketing surveillance of the performance of these systems; and vendor accountability.
From the Swedish Medical Products Agency:
Improving patient safety in the EU: Many Medical Information Systems should be classified as Medical Devices
Thursday, June 18, 2009
Correctly functioning Information Technology (IT) systems for health care is a prerequisite for ensuring patient safety. However, applicable regulation is rarely applied, mainly due to the lack of useful guidelines on how to classify the IT-systems [guidelines whose formulation has been resisted for many years by the HIT industry, I might add - ed.] A national working group in Sweden has prepared a guidance report that will help increase compliance with the Medical Device regulation in the EU, thus improving patient safety.
An increasing number of serious incidents, with IT-systems involved, have been reported from the health care sector in recent years [but largely covered up in part due to contractual gag clauses on HIT sales and resultant violations of healthcare leadership fiduciary responsibilities - see this link - ed.] In most of these cases, existing regulatory regimes have not been applied, either by manufacturers or by health care providers. As a result, the assessment of safety issues has become unclear because the manufacturer’s responsibility is vague. [It's not vague; it's contractually absent - ed.]
For this reason, in 2008 the Swedish Medical Products Agency (MPA) initiated a national working group with the aim of providing guidelines for the classification of IT-systems intended to be used in health care. The working group has now prepared a report, intended to serve as guidance for both manufacturers and end-users. At present, there are no guidelines of this kind in Sweden, or the rest of Europe.
“Many parties, including the European Commission, have expressed interest in our work. We believe that it will improve the quality and safety of medical information systems. [Finally -ed.] A common approach to product classification is key” says Lennart Philipson, Scientific Director.
One important conclusion from the working group is that the Medical Device Directives is the most suitable regulation to be applied.
“Our market surveillance of medical information systems will be based on the conclusions in the report from now on. If a system falls within the definition of a medical device, the requirements for CE-marking [Conformité Européene, a branding mark - ed.] shall be applied” says Mats Ohlson, Chairman of the working group.
Manufacturers need to adapt to applicable standards when it comes to quality systems, risk management and usability. They will also need to establish post-market surveillance routines to regularly assess products on the market.
The working group consisted of members from the Swedish Medical Products Agency, the National Board of Health and Welfare, the Swedish Association of Local Authorities and Regions, Swedish Medtech, the Swedish Standards Institute, Swedish Electrical Standardization and notified bodies through Intertek Semko.
A report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" is available in English translation at this link (PDF).
Download and read the entire report.
Highlights:
This section gets to the heart of the matter regarding electronic medical records:A general opinion of the health care providers represented in this Working group is that from a patient safety point of view, it is desirable that stand alone software and systems intended to, directly or indirectly, affect diagnosis, health care and treatment of an individual patient [what I have referred to a "mediating aspects of care" - ed.] shall be regulated under a Product Safety Regulation.
The Working group has not been able to define any other appropriate regulation than the Medical Device Directive when it comes to the definition of such systems. Adherence to the Medical Device Directive is important so that manufacturers and clients can work with the same intentions. [I would add that the intentions are not exactly the same; the manufacturers' intentions are, by necessity, to maximize profits - ed.] This project report serves as one step towards the clarification regarding which conditions that shall apply.
The Working group believes that software intended for a medical purpose must be regarded as a "device" [indeed - ed.] and expressions such as "project", "service" and similar must be avoided describing a Medical Information System. This approach has advantages since a product safety regulation, such as the Medical Device Directive, can be applied and the product will have:
• a defined intended use
• defined and documented specifications
• a manufacturer with a clear responsibility until the delivery is accepted
• a controlled ”Post Market” surveillance
Furthermore, the Working group believes:
• that the Medical Device Directive shall be applicable for software and systems that fulfills the definition of a medical device
• that the manufacturer of the intended systems shall follow the appropriate validation method [e.g., as in the pharma industry's IT - ed.] in the Medical Device Directive
• that the level of risk shall be assessed, motivated and control the classification and verification method
• that applicable standards shall be followed for design, verification and validation regarding software and information systems that are medical devices
• that there is no legal requirement that manufacturers of devices in the lowest device classes must have certification for their operational processes to fulfill the Medical Device Directive. The Medical Products Agency has in these cases no mandate to formally demand certification, such as for instance ISO 13485. However, in reality it is still necessary to have some form of a functional quality management system to manage a proper design process for software systems [due to the fact that patients, ethical issues, and human rights issues are involved - ed.] as well as the necessity to fulfill the Post Market Requirements including Vigilance reporting.
• that the prerequisite for a successful and fair application of the regulation assumes that health care providers demands that such systems shall be CE‐marked and be regarded as medical devices
• that a controlled and standardised verification method when performing installation work in a user’s network, supported by the manufacturer, is an essential supplement to the manufacturer’s CE‐marking and a prerequisite for an acceptable safety level when using the device.
8.2.3 Electronic patient records
Electronic patient record systems are more than an archive for just documents, they also have features for compiling and transferring information to be used for decision making. Patient records are the basis for documentation and planning of diagnosis, therapy and follow‐up, especially when it comes to drug prescriptions and recommendations. [These caveats include CPOE systems as well - ed.]
It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.
Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents that has been reported to the Swedish National Board of Health and Welfare. [It would be interesting to know more about this "series of incidents" - ed.]
Finally, in the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:
... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.
HIT can be a facilitator (not a replacement or revolutionary tool) to physicians, if done well, and not overdone to the point of costing far more than entire new hospitals or hospital wings. There is no replacement for a physician with a strong background in the preclinical and clinical sciences, ethics, critical thinking, and the scientific method. Computers are not a miracle. They can help provide facts, but cannot fundamentally turn a poor physician into a Marcus Welby. Verghese on that issue:
To come back to my favorite painting: a computer cannot take the place of the doctor in Fildes’s painting ["The Doctor", 1891, see below - ed.]; an electronic medical record (EMR) may or may not save money (it won’t be anywhere as much as is projected) but what it will do is ensure that we doctors, nurses, therapists, particularly in hospitals will be spending more and more time focused on the computer, communicating with each other, ordering and getting tests, buffing and caring for our virtual patient—the iPatient is my term for this phenomenon—while the patient in the bed wonders where everybody is. Having worked exclusively for the last seven years or so in hospitals that have electronic medical records (EMR), I have felt for some time that the patient in the bed has become an icon for the real focus of our attention, the iPatient. Yes, electronic medical records help prevent medication errors [only when done well, see Koppel - ed.] and are a blessing in so many ways, but they won’t hold the patient’s hand for you, they won’t explain to the family what is going on.
"The Doctor", 1891 (Sir Luke Fildes, 1843-1927)I will go a step further. It is now clear that the promises of massive savings from electronic medical records, usually originating from vendors based on hearsay or cherry-picked, favorable but flawed studies that dismiss a growing body of other literature (such as in Cerner CEO Neil Patterson's hyper-ebullient piece here), have been deliberately manufactured by a lobby of industry pundits.
It is only now that I more fully comprehend the origins of and motivations behind the "we will revolutionize medicine" fervor exhibited by HIT company CEO's, such as I experienced and wrote about starting back in the 1990's. From my 1999 essay "What is Medical Informatics, and Why is it an Important Specialty":
... A letter I had written [in Feb. 1999 - ed.], "Broken Chord" published in the journal Healthcare Informatics, further amplifies the skills and experience issue. The letter addressed issues of skills, insights, and roles of MIS personnel in healthcare settings. I described a Microsoft Healthcare Users Group conference attended predominantly by healthcare MIS staff and vendors, where I observed a panel discussion moderated by the CEO of HBOC [before he was found to be cooking the books - ed.] and composed of several other industry CEO's. The panel was discussing how they would revolutionize healthcare through their leadership in information technology.
During the Q&A period I asked the audience how many really felt they would revolutionize medicine through their leadership in IT. Several hundred--almost all in the audience--raised their hands. I then asked how many had ever taken care of patients or examined any textbook of medicine, such as Harrison's Textbook of Internal Medicine or the Merck Manual. A minority of hands went up. This suggested, in my view, a striking deficiency of knowledge, experience and insight on the part of the de facto clinical information technology leadership, complicated by rather cavalier attitudes regarding the essential role of clinical expertise.
I believed what I was hearing to be irrational exuberance, not manufactured exuberance.
Quality improvements are possible under the most controlled of environments, such as here (such projects are not easily portable, unfortunately). Massive cost savings? When organizations are spending upwards of $100 million just for system implementation, not including ongoing lifecycle costs, massive savings projections from HIT are risible.
One would think that after Madoff, Stanford and other recent financial confidence scandals, that bright people would be more skeptical of "massive returns, always and forever" promises, but that does not appear to be the case. With regard to mass savings, I make the prediction that in 2014, as in the UK today, our government, healthcare management, and medical professionals will realize, Madoff style, that they've been had.
So, Health IT Industry executives, pundits, and consultants, can we drop the grandiose "we will revolutionize medicine!" and "massive savings" myths, and focus on facilitating clinicians and on quality improvement, please?
6/22/09 Addendum
The U.S. Food and Drug Administration (FDA) and Sweden's Medical Products Agency are no strangers.
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