Novel Idea on Healthcare IT: Worth a Billion Dollars!

From an AMIA announcement:

CMS Innovation Center Announces $1 Billion Funding Opportunity:

CMS announced a new initiative, the Health Care Innovation Challenge, which will provide grants for new ideas to improve care and lower costs for those in Medicare, Medicaid and CHIP. CMS will award up to $1 billion in grants for a 3 year period and is encouraging providers, payers, local government, public-private partnerships and multi-payer collaboratives to develop new and innovative ways to improve care. To learn more about the grants and application process, check out the CMS Innovation Center website and be sure to register for the CMS webinar on Thursday.

CMS, I have an idea!

It's a really, really novel idea!

"Let's regulate HIT to improve its safety, usability, usefulness, fitness for purpose, effectiveness, etc." ™

That will lower healthcare costs! Save lives, too!

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Can I have my Billion Dollars now?

You can do a lot in health IT with a billion dollars - if you're not the HIT industry, that is, that has squandered a large wad of these over the past several decades.

-- SS

Abbott Laboratories to Settle for $1.3 Billion Allegations Including Giving Doctors Kick-Backs and Training Them to Make False Diagnoses

It looks like the march of billion dollar legal settlements by health care organizations is on its way again. 

The Proposed Abbott Laboratories Settlement

Last month Bloomberg reported:
Abbott Laboratories (ABT) agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said.

Abbott executives, federal prosecutors and state officials reached a tentative agreement calling for the drugmaker to pay about $800 million to resolve civil claims over Depakote and about $500 million in criminal penalties for marketing the epilepsy medicine for unapproved uses, said three people familiar with the settlement who declined to be identified because the agreement hasn’t been made public. Abbott said earlier this week it was reserving $1.5 billion to cover costs of the potential settlement.

A billion here, and billion there, it begins to add up:
The settlement would be the third-largest illegal pharmaceutical marketing accord in U.S. history, behind the $2.3 billion Pfizer paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine.

Encouraging Dishonesty, Giving Kick-Backs

The Bloomberg report only briefly discussed the behavior by Abbott that lead to the settlement:
In February, the government joined cases brought by former Abbott employees alleging the company engaged in so-called off-label marketing starting in the late 1990s. The suits contend the illegal sales practices resulted in false claims being submitted to government health programs.

The whistle-blowers claim the drugmaker marketed Depakote for unapproved uses including agitation and aggression in patients with dementia, autism, sexual compulsion and other disorders.

However, an article published last week in the Chicago Tribune further described the allegations made by the whistle-blowers. In summary,
The lawsuits against Abbott allege that the company encouraged and trained sales reps to market Depakote off-label to nursing home directors, geriatric doctors and other long-term care facilities. The company also gave doctors illegal kickbacks to talk about off-label uses of the drug in an effort to boost sales, according to the lawsuits, which were filed in federal courts in Virginia, Illinois and the District of Columbia.

The FDA approved Depakote in 1983 to treat certain seizures in adults and children over 10. Since then, the drug has received approval for the treatment of other types of seizures, manic episodes of bipolar disorder and the prevention of migraine headaches.

However, Depakote was never approved to treat Alzheimer's disease or other types of dementia or for general treatment of bipolar disorder.

According to the whistle-blower lawsuits, though, Abbott sales reps specifically marketed Depakote to treat agitation and aggression associated with dementia.

One whistle-blower alleged that Abbott encouraged doctors to make false diagnoses that would enable the government to pay for the use of Depakote:
During a nationwide conference call in 2007, an Abbott trainer allegedly coached sales reps on how to explain to doctors that they could miscode a patient's illness in order to bypass federal regulations. For example, a physician could code a patient as having 'late onset of bipolar' or 'underlying seizure disorder' instead of 'agitation associated with dementia,' according to her complaint.

Abbott held training sessions focused on off-label promotion but brought in outside consultants and held the training away from its North Chicago headquarters.

At one training event, McCoyd and another sales representative allegedly were asked to share their techniques for off-label marketing but were forbidden from preparing or distributing any written materials about the topic.

Upper-level management who attended the sales training purposely left the room when the off-label training sessions began, according to the complaint.

The whistle-blowers also alleged that Abbott gave kick-backs (presumably the same idea as bribes) to doctors for prescribing Depakote:
The complaints also allege that doctors were given kickbacks to talk about off-label uses of Depakote.


According to McCoyd's filing, Abbott salespeople were given about $20,000 to $30,000 each year to 'educate' physicians and other heath care providers about off-label use of Depakote.

Abbott paid doctors who promoted the drug between $500 and $2000 per speech, the complaint states. The money allegedly was funneled through intermediaries and associations, including the Alzheimer's Association, although the association told the Tribune it has 'no knowledge' of such activities.

Using the organizations to pay doctors was done to 'disguise the direct payments to doctors and Abbott's substantial and direct involvement' in the events, the complaint alleges.

Summary

So it appears that Abbott is about to settle a case involving some very serious allegations, including training physicians to make false diagnoses, and giving physicians kick-backs. These sort of actions seriously subvert physicians' core values (and any physicians who made such false diagnoses or accepted such kick-backs would have seriously violated core ethical principles.)

These actions also may have directly harmed patients. There appears to be no good evidence that Depakote has benefits that exceed its harms for patients with dementia, autism, etc. So encouraging doctors to prescribe the medicine for these patients was likely to have subjected some patients to side-effects without providing them any benefit. That would contradict the physicians' obligations to put the interests of individual patients first, and to avoid harming them. As the Tribune article noted,
[Dr Adriane} Fugh-Berman, with PharmedOut, said companies put patients at risk when they promote drugs that haven't gone through the FDA's regulatory process.

'These drugs are being promoted for conditions they have not been shown to be effective, and they might be dangerous,' she said.

So a $1.3 billion penalty would actually be a cheap price to pay for such ethical offenses. Note that the Bloomberg report did mention "criminal penalties," so this may be one of the infrequent cases in which a big health care organization actually would plead guilty to some crime.

Note however that neither article mentioned anything about any individual who authorized, directed, or implemented the conduct in question suffering any negative consequence or paying any penalty. These reports are preliminary, so it may be that such penalties are part of the final settlement. But it is also possible that this settlement becomes another, and particularly flagrant example of health care corporate executive impunity.

If no one turns out to have to pay a penalty for training physicians to lie to the government, and giving them kick-backs to prescribe a possibly useless and likely harmful medicine, what will deter other executives from authorizing and directing such actions again to make more money? Note in the Bloomberg article:
Sales of Depakote 'rocketed to over $1.4 billion per year' as a result of improper marketing, according to a complaint filed in February by ex-Abbott sales representative Meredith McCoyd. 'Compensation for senior executives soared as well.'

Furthermore, if no one turns out to have to pay a penalty for these actions, this case will just contribute to the ongoing demoralization of health care professionals. It will be another example of how insiders take advantage of the system for their personal gain, to the disadvantage of patients, and at further cost to an already overly expensive health care system that fails to provide adequate access and quality care.

So I repeat, repeat, repeat... to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

EMR Defects That Injure and Kill, and Litigation: A Hospital Is Paying a Huge Hourly Rate for This?

At my Oct. 2011 post "A Diary of EHR-Initiated Tragedy" I wrote that:

... I've realized that these past posts, when integrated for an upcoming investigation, tell a story that is probably not uncommon in hospitals today. They form a sort of Diary of EHR-Initiated Tragedy.

Sadly, this Diary was my account of my own mother's EHR-related injuries.

There is a new chapter brewing.

In the latest objections to the Complaint against the hospital and its agents, the retained defense attorney proffered this argument:

(ii) Plaintiff's Software Design Defect Claims are Preempted by the Federal HITECH Act.

• To the extent Plaintiff attempts to bring a common law product liability claims against defendant hospital for required use of EMR software, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.S. 201, 300 et seq.

• Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id. [See note below - ed.]

• The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts and state law that conflicts with the exercise of federal power. Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141m 102 S. Ct. 3014 (1982). "Pre-emption may be either express or implied, and 'is compelled whether Congress' command is explicitly stated in the statute's language or implicitly contained in its structure and purpose." Matter of Cajun Elec. Power Co-Op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977).

• In this case, to impose common law liability upon defendant hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress' statutory scheme for fostering and promoting the implementation and use of EHR.

In other words, the HITECH Act gives hospitals free license to implement clinical information technology poorly with impunity, based on cases in banks, power companies and meat-packing plants, and HHS certification means HHS has found HIT is safe and effective.

[Note]: On "... The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended." HHS does not design or certify EMRs. Is that assertion just made up out of thin air?

Regarding "to the extent Plaintiff attempts to bring a common law product liability claims against defendant hospital for required use of EMR software", that's just made up. There is no requirement for the use of EMR software.

On HIT "certification" implying safety and effectiveness, not exactly. "Certification" is entirely irrelevant. I had previously written here that:

"Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the CCHIT web pages for example. ("CCHIT Certified®, an independently developed certification that includes a rigorous inspection of an EHR’s integrated functionality, interoperability and security.")

Health IT "certification" is not like Underwriters Laboratories (UL) certification of appliances. ("Independent, not-for-profit product safety testing and certification organization ... With more than a 116-year proven track record, UL has been defining safety from the public adoption of electricity to new breakthroughs that help protect our future. UL employees are committed to safeguarding people, places and products in new and innovative ways for today’s borderless world.")

"Highly regulated industry?" I guess that's why the Institute of Medicine just completed a report that concluded that health IT safety is unacceptable, that regulation is lacking, and that the health IT industry best get its act together voluntarily, or FDA will have to step in:

... the push [by the Administration] is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety.

... The current state of safety and health IT is not acceptable; specific actions are required to improve the safety of health IT. The first eight recommendations are intended to create conditions and incentives to encourage substantial industry-driven change without formal regulation. However, because the private sector to date has not taken sufficient action on its own, the committee believes a follow-up recommendation is needed to formally regulate health IT. If the actions recommended to the private and public sectors are not effective as determined by the Secretary of HHS, the Secretary should direct the FDA to exercise all authorities to regulate health IT.

As to the assertion that "to impose common law liability upon defendant hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress' statutory scheme for fostering and promoting the implementation and use of EHR", let's repeat:

There are no federal laws and regulations for Health Information Technology.

The technology is unregulated. I could design an EMR tonight and put it up for sale tomorrow. It might not qualify for federal incentives if it were not "certified" by an ONC-Authorized Testing and Certification Body (ONC-ATCB), but if I could find a buyer willing to use it, there are no laws or regulations preventing that. From the ONC FAQ here:

... In order to qualify for Medicare and Medicaid EHR incentive payments, providers must use EHR technology that has been certified by an Office of the National Coordinator for Health Information Technology-Authorized Testing and Certification Body (ONC-ATCB, or ATCB). The temporary certification program provides assurances that the EHR technology adopted by health care providers is technically capable of supporting their efforts to achieve meaningful use.

As to imposition of such a common law liability "conflicting with a Congressional scheme for promoting EHR's", that is simply irrelevant.

I note the assertion is also defamatory towards Congress, implying Congress is fine with hospitals deploying
health IT with reckless abandon, and should be permitted to do so with legal impunity for the sake of their "scheme."

There's also a claim made that the defendant hospital is not on the hook for EHR defects in their installed systems, because they "don't sell or manufacture the product."

They do, however, modify, customize, maintain, and test it for proper functioning in situ (the latter if they are acting responsibly, especially since the technology is experimental and not tested/approved by FDA, not even undergoing "fast track" 510(k) approval). It should also be noted that the latter 510(k) process does not confer freedom from user liability even when it is obtained.

Even to my non-legally-trained mind, I believe the duties that hospitals owe patients include these, especially with a non-FDA approved experimental technology known to cause risk, injury and death but at a magnitude that is not known:

  • The duty to make a reasonable inspection of equipment it uses in the treatment of patients and remedy any defects discoverable by such inspection.
  • The duty to provide equipment reasonably suited for the use intended.

Finally, as it turns out, the ED EHR in question was not "certified" when my mother became injured. It was not "certified" until many months later.

Additionally, the hospital in question made its buy decision and did its implementation several years before HITECH (enacted as part of the American Recovery and Reinvestment Act of 2009) was even a twinkle in the Administration's eye.

If I were paying handsomely for legal counsel such as outlined above, I'd cringe.

Sadly, while legal obstructionism continues (as I am finding is common regarding health IT-related litigation), more patients are being injured and killed.

-- SS

The Parallels Between Health Care and Financial Dysfunction: Leadership's Impunity as Demonstrated by the Citigroup Case

For years, we have noted the parade of legal settlements made by large health care organizations.  The parade is notable on one hand because it illustrates how often some of our best known health care corporations and institutions behave badly. 

Impunity for Health Care Leaders

It is notable on the other hand because it illustrates how the leaders of these organizations have virtual impunity.  In very few cases has any person who authorized, directed, or implemented bad behavior faced any negative consequences.  The executives of these organizations often have gotten to continue making millions of dollars while the financial costs of settlements are borne by the company as a whole, and hence by all the employees, no matter how poorly paid or uninvolved, and all stockholders, no matter how powerless they were to prevent the bad behavior.

The legal settlements that now seem to be the only effort made by the government to ensure fairness, honesty, and a level playing field in the health care "industry" seem to have no deterrent effect.  Some of the most famous health care companies have been subject to successive settlements, each of which failed to deter the next bout of bad behavior.  For example, we just posted about NINE separate settlements made by global pharmaceutical giant Pfizer Inc from 2002 to 2011, the largest for $2.3 billion.  Yet a succession of Pfizer CEOs made tens of millions a year, and left with golden parachutes (see post here).  Johnson and Johnson subsidiaries have settled with corporate guilty pleas to several misdemeanors, while the company CEO made tens of millions a year and served as an adviser to the President.  (See summary of offenses here, CEO's compensation here, and his White House role here.) 

With the rise of the "Occupy Wall Street" movement and its spin-offs, and the resurgence of the global financial crisis now threatening the Euro-zone in particular, the discussion of how the world's finance system has become fiercely dysfunctional that should have occurred after the crisis began in 2008 is now starting.  That discussion has now focused on the relative impunity of the leadership of finance firms, a striking parallel to what has gone on in health care.

The Citigroup Settlement

The case that has created headlines is that of Citigroup, and a new settlement of allegations brought against it by the US Securities and Exchange Commission (SEC).  A commentary by Jonathan Weil in Bloomberg explained it thus:
Five times since 2003 the Securities and Exchange Commission has accused Citigroup Inc’s main broker-dealer subsidiary of securities fraud. On each occasion the company’s SEC settlements have followed a familiar pattern.

Citigroup neither admitted nor denied the SEC’s claims. And the company consented to the entry of either a court injunction or an SEC order barring it from committing the same types of violations again. Those 'obey-the-law' directives haven’t meant much. The SEC keeps accusing Citigroup of breaking the same laws over and over, without ever attempting to enforce the prior orders. The SEC’s most recent complaint against Citigroup, filed last month, is no different.

As in most of the health care cases, Citigroup has been subject to multiple legal settlements, each of which apparently failed to deter the next bit of bad behavior. Also, while the SEC made the company promise in particular settlements not to misbehave again, the SEC never held the company accountable for these promises.

Other features of the Citigroup settlement paralleled many of those in health care. The company was never made to admit bad behavior. No top executive ever paid any penalty.

However,unlike many health care cases, the Citigroup case produced an uproar, partially because the presiding judge refused to accept the settlement without questions.

A Judge Questions the Settlement

Instead, the judge had caustic questions for both the SEC and Citigroup. For example, as reported by the Washington Post,
A federal judge Wednesday challenged the SEC’s plan to settle a fraud case against Citigroup for $285 million, saying that the deal would recoup only a fraction of investors’ losses and would leave the firm free to proclaim its innocence in private lawsuits over the remaining damages.

The judge used the Citigroup case to mock the SEC’s traditional way of doing business — allowing defendants to settle without admitting or denying wrongdoing.

The unproven allegations, U.S. District Court Judge Jed S. Rakoff said, 'are no better than rumor or gossip.'


'Does not the SEC of all agencies have an interest in establishing what the truth is?' Rakoff asked.

Also, he mocked the SEC practice of requiring promises of good behavior, that go unenforced,
SEC settlements routinely include court orders prohibiting defendants from committing similar violations in the future and exposing them to potentially severe consequences if they do. However, the agency has refrained from enforcing those injunctions against repeat offenders.

Citigroup was subject to two injunctions that predated the current case, SEC chief litigation counsel Matthew T. Martens said.

Rakoff suggested that the injunctions are 'just for show.'

The SEC lawyer said the agency takes past offenses into account when determining an appropriate penalty. Other SEC officials said after the hearing that past injunctions can be enforced only when the SEC catches a defendant in an ongoing violation.

The proposed settlement also calls for Citigroup to take remedial steps to reduce the risk of future violations; Rakoff asked if those were merely 'window dressing.'

This unusual hearing was covered by the Wall Street Journal, the New York Times, Bloomberg, and other major media outlets.

Finance's Own Parade of Settlements

Meanwhile, the NY Times did some in-depth reporting to show that the Citigroup case was hardly a fluke. There has been a parade of legal settlements of bad behavior by finance firms paralleling the parade we have discussed by health care organizations, although the former occurred without there being a "Finance Renewal" blog to comment on them. As written by Edward Wyatt,
Citigroup is far from the only such repeat offender — in the eyes of the S.E.C. — on Wall Street. Nearly all of the biggest financial companies, Goldman Sachs, Morgan Stanley, JPMorgan Chase and Bank of America among them, have settled fraud cases by promising the S.E.C. that they would never again violate an antifraud law, only to do it again in another case a few years later.

A New York Times analysis of enforcement actions during the last 15 years found at least 51 cases in which 19 Wall Street firms had broken antifraud laws they had agreed never to breach.

In particular,
Of the 19 companies that the Times found to be repeat offenders over the last 15 years, 16 declined to comment. They read like a Wall Street who’s who: American International Group, Ameriprise, Bank of America, Bear Stearns, Columbia Management, Deutsche Asset Management, Credit Suisse, Goldman Sachs, JPMorgan Chase, Merrill Lynch, Morgan Stanley, Putnam Investments, Raymond James, RBC Dain Rauscher, UBS and Wells Fargo/Wachovia.

The NY Times article also found some experts willing to criticize the current effeteness of government regulation and law enforcement:
Senator Carl Levin, a Michigan Democrat who is chairman of the Senate permanent subcommittee on investigations and has led several inquiries into Wall Street, said the S.E.C.’s method of settling fraud cases, is 'a symbol of weak enforcement. It doesn’t do much in the way of deterrence, and it doesn’t do much in the way of punishment, I don’t think.'

Barbara Roper, director of investor protection for the Consumer Federation of America, said, 'You can look at the record and see that it clearly suggests this is not deterring repeat offenses. You have to at least raise the question if other alternatives might be more effective.'

Also,
some experts view many settlements as essentially meaningless, particularly since they usually do not require a company to admit to the accusations leveled by the S.E.C. Nearly every settlement allows a company to 'neither admit nor deny' the accusations — even when the company has admitted to the same charges in a related case brought by the Justice Department....

Summary

As we learn more about what has gone wrong with our political economy, the parallels with what has gone wrong with health care become more obvious. Of course, health care must operate within a larger environment, and there has been increasing overlap between the leadership of finance and of health care.

As the economy continues to sag, with rising unemployment and under-employment, increasing foreclosure, homelessness and poverty, and the decreasing likelihood of an even minimally comfortable retirement for many, it appears peoples' minds are increasingly focused on what has gone wrong, and particularly how ill-informed, incompetent, self-interested, conflicted and corrupt leadership of financial firms has lead to this severe economic dysfunction.

I also hope that as the health care crisis continues to worsen, with rising costs, decreasing access, and degrading quality, peoples' minds will also increasingly focused on what has gone wrong, and particularly, as we have been saying for nearly seven years, how ill-informed, incompetent, self-interested, conflicted and even corrupt leadership of health care organizations has lead to this severe health care dysfunction.

Maybe someone will now take seriously our calls for... true health care reform that requires competent, ethical leadership that upholds health care's core values within a governance structure of accountability, integrity, transparency, and honesty. Tackling the deep problems in health care will require tackling the deeper problems in the global political economy which helped to generate them.

EHRevent.org Leadership: "Heck, getting out of bed in the morning is dangerous- it just beats the alternative"

I have posted about the organization EHRevent.org on numerous occasions. I expressed concerns that this organization's representation as an alternative aggregator of health IT difficulty cases, compared to established organizations and resources such as FDA's Medwatch and MAUDE database, was probably not a good idea:


November 15, 2010: EHRevent.org: Web Site to Collect EHR Safety Reports

November 16, 2010: EHRevent: survey amateurism, bias, or something else?

November 17, 2010: Some answers about new site "EHRevent.org" for health IT and drug adverse event reporting

November 22, 2010: EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

July 24, 2011: EHRevent.org and "The National Database of EHR Errors Being Called For" - Where's the Beef?

The Nov. 22, 2010 post "EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error? " is particularly relevant to this one.

I saw the following remarkable comment by EHRevent.org CEO Edward Fotsch MD on the HISTalk blog. It was in a comment section regarding the new Institute of Medicine report "Health IT and Patient Safety: Building Safer Systems for Better Care" on health IT risks (my initial post on that topic is here):


ed fotsch Says:

Re: the IOM/ONC report it seems to me that the IOM started with the wrong question. Question #1 posed should have been- ‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices; as opposed to the question that apparently was posed: ‘are EHRs safe.’

Heck, getting out of bed in the morning is dangerous- it just beats the alternative. Once question #1 HAD been answered, question #2 could have been tee’d up- ‘How can we make EHRs better?” But that ship has sailed and now they and we in Tidy-Bowl mode. The wrong question was asked so we’re dealing with what may be the right answer to the wrong question. And it will be hard to get the toothpaste back in the tube, worms back in the can, etc. on this one from an ONC/IOM standpoint- and yes the press will have a field day, those running for office will have more fodder and Republicans (no issue per se with Republicans BTW) who are pushing for less (not more) government regulation will have a field day with this set of recommendations.

November 8th, 2011 at 10:53 pm

While I do not know Dr. Fotsch, my questions about this comment are as follows:



  • Are its viewpoints entirely objective with regard to health IT?

  • Is it consistent with a physician-executive who thinks critically about risk, and knows the literature (such as here), or with someone who leans toward technologically deterministic views about healthcare IT?

  • Is it a reasonable view from the CEO of an organization seeking a position of enormous public responsibility as the "central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records", as described of EHRevent.org in the aforementioned Nov, 22, 2010 post?

  • It is an appropriate comment for someone holding such a position?

These questions repeat some of the concerns as expressed in my previous posts.

I responded as follows at HIStalk in the same comment thread. Emphases in the original:


To Dr. Fotcsh:

My opinion differs. I believe the IOM asked the correct questions.

The answer to your proposed question “‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices” is – nobody really knows. The IOM explicitly acknowledges this:

----------------------------------
… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”
----------------------------------

The technology is experimental.

In my opinion, that invokes the medical adage “First, do no harm.” There exist protocols for human subjects experimentation. The health IT industry has exempted itself from those protocols.

My overall thoughts on the IOM report are at http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html

-- SS