‘Go to the devil.’ - Don’t you dare pray, @GovBillLee. My son’s on lockdown at the school where your wife & I taught your kids. God spared your child a gun death. You thanked h...
5 hours ago
Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.
now the hospital can do a world of good by helping the medical community learn from its experiences. This requires complete transparency and truth-telling
'Unfortunately, in our initial treatment of Mr Duncan, despite our best intentions and highly skilled medical team, we made mistakes,' Varga wrote in testimony to the US Congress. 'We did not correctly diagnose his symptoms as those of Ebola. We are deeply sorry.'
[To] claims that Duncan remained in an area with other patients for several hours before he was placed in isolation. Hospital officials said he was isolated immediately.
[To] complaints that personal protective equipment was inadequate and left them exposed, particularly at the neck. Nurses said they had to use penetrable medical tape to try to protect themselves. The hospital defended the equipment, saying it met the CDC’s guidelines at the time. Hospital officials said that it was the CDC that recommended using tape to pinch together the necks of the protective gowns and that hoods were ordered for the staff after concerns about the tape were raised.
The hospital's response -- its second in two days -- in part shifted responsibility to the federal Centers for Disease Control and Prevention and to the protocols the agency issued this summer to guide the handling of a patient infected by the virus, which is thought to have killed more than 4,400 people in West Africa. The hospital said the protocols changed frequently, frustrating caregivers and management.
The hospital also blasted 'third parties who ... are seeking to exploit a national crisis.' That was a dig at the National Nurses United union, which does not represent the Dallas hospital's nurses, but which made their complaints available to the media.
'Many of the comments we have seen or heard in the media are only loosely based on fact, but are often out of context and sensationalized,' the hospital statement said. 'Others are completely inaccurate.'
In televised interviews Thursday, Aguirre said she feared retaliation for speaking out about worker protection. An attorney accompanied her during the interviews.
“Texas Health Dallas has a strict non-retaliation policy,” the hospital statement said. “Employees are encouraged to raise issues and concerns via the chain of command.”
Presbyterian 'is a safe place for employees and patients,' Berdan said in a full-page ad Sunday in The News.
Pitched as a 'letter to our community,' Berdan again apologized for mistakes the hospital made in Duncan’s treatment and in failing to have deployed fully its training and education programs before the virus struck. He said the hospital hasn’t determined how the nurses became infected.
On Monday afternoon, dozens of nurses, doctors and other healthcare employees convened at the front entrance of Texas Health Presbyterian Hospital to discuss the recent controversy about how the hospital handled the Ebola outbreak. Despite definitive comments in support of the hospital, Presby's nurses remained tight-lipped on what actually happened during Thomas Eric Duncan's care.
'Today we want our community and our country to know that the nurses at Texas Health Presbyterian are so proud of our hospital and proud of what we do,' said Dr. Cole Edmonson, chief nursing officer at the hospital. 'There are a lot of questions being asked about what happened. And I can't answer those today. A number of reviews are underway.
vowed,'our family will fight for transparency, accountability and answers, for my uncle and for the safety of the country we love.'
We’ll never know whether the secret settlement announced Wednesday included any of the things Weeks indicated he was so determined to get.
What the public will probably never know, thanks to the secret settlement, are the details of who said — and did — what to whom when Thomas Eric Duncan went to Presbyterian on Sept. 25.
It was really important to make sure we had a really high level of communication and maintained the trust level inside the organization while we were in many cases being attacked from the outside, as the world moved really from science to political science to social science to superstition and fear
Defendants deny that they have violated the federal securities laws or any laws and maintain that their conduct was at all times proper and in compliance with all applicable provisions of law.
A Lake County jury awarded almost $10 million to a former Hospira employee, finding that the company fired him because he raised concerns that it covered up quality and safety issues with a product.
The former employee, Angel Estrada, was a vice president of quality systems and compliance for the Lake Forest-based pharmaceutical company from September 2010 to September 2011, when the company fired him, according to a lawsuit filed in Lake County Circuit Court.
Estrada raised concerns to supervisors that Hospira was not addressing issues in one of its medical pumps that a hospital in Spain reported to the company. The hospital reported that air bubbles had occurred in the device when used on children, which can cause fatalities, according to the complaint.
The lawsuit alleges that Estrada reached out to his superiors, including Hospira CEO Michael Ball, to address the reported issues and notify the FDA and European regulators of the pump's alleged defects.
The lawsuit alleges that on the same day Estrada sent Ball a report, two employees under Estrada were fired 'purportedly for altering a record during the course of an audit.' Hospira fired Estrada 'under the pretext of not properly investigating' one of the employee's conduct during the audit, the lawsuit says.
The real reason he was fired 'was to quash his reporting of the dangers associated' with the pump, the suit alleges.
The jury issued its verdict earlier this month. Of the almost $10 million Estrada was awarded, $7 million was punitive damages.
Hospira said it will appeal and that it maintains that the allegations are 'fully without merit.'
The U.S. government is losing the war against white collar crime.
That's the message from Sam E. Antar, one of the masterminds of the massive Crazy Eddie fraud of the 1980s.
'We are in the golden era of white-collar crime. My biggest regret is I should've been a criminal today rather than 20 years ago,' Antar told CNNMoney on the sidelines of a New Jersey securities fraud summit.
Antar drew a big round of applause when he pointed out that no one from Wall Street went to prison because of crimes that led to the financial crisis.
'We are devoting far less resources to combating crooks like myself today than back in my day,' he said.
Antar knows a thing or two about corporate fraud. He served as Chief Financial Officer of Crazy Eddie, the electronics retailer that became one of the symbols of white-collar crime in the 1980s.
Known for its loud commercials promising "INSAAAANE" prices, Crazy Eddie got into trouble for understating income to avoid taxes and then committing securities fraud once it decided to go public.
'Crazy Eddie was from Day One planned to be a criminal enterprise. We committed our crimes simply because we could,' said Antar, whose cousin Eddie Antar founded the chain.
Because he 'showed the feds where the bodies were buried,' Antar got off with only six months of house arrest, community service and tens of thousands of dollars in civil penalties. Crazy Eddie co-founder Eddie Antar served more than six years in prison.
Today, the convicted felon is advising the government and private companies about white-collar crime. Antar expressed frustration with the government's failure to put Wall Street bankers behind bars.
'We have turned prosecutors into tax collectors,' he said. 'Corporations don't commit crimes, people commit crimes.'
Biotronik, Inc, the Lake Oswego medical device manufacturing firm, will pay $4.9 million to the federal government to resolve allegations that the firm paid kickbacks to doctors in Nevada and Arizona to use its products.
The settlement resolves allegations that Biotronik, through the payment of kickbacks to physicians, caused hospitals and ambulatory surgery centers to submit false claims to Medicare and Medicaid for the implantation of Biotronik pacemakers, defibrillators and cardiac resynchronization therapy devices.
Biotronik allegedly induced electrophysiologists and cardiologists practicing in Nevada and Arizona to continue using Biotronik devices, or to convert to Biotronik devices, by paying the implanting physician in the form of repeated meals at expensive restaurants and inflated payments for membership on a physician advisory board.
The state recently concluded a court case against two Salem doctors who put heart implants into patients without telling them that a manufacturer's training program put a sales representative into the operating room. The [Oregon] DOJ accused the doctors in the civil case of having 'misrepresented' their services as 'for the exclusive benefit of the patient' and 'concealing' from patients payments that created a potential "incentive" to use Biotronik implants -- defibrillators and pacemakers. The surgeons received between $400 and $1,250 for implant surgeries when a trainee was present.
cardiologists Matthew Fedor and Kyong Turk admitted no wrongdoing but agreed to pay $25,000 each and inform future patients of any payments from a drug or device maker in connection with their services to that patient and when admitting sales representative trainees to the operating room.
At Biotronik's U.S. headquarters in Lake Oswego, president Jake Langer called the state's case unfair and detrimental to good health care.In 2011, Documents Revealed Biotronik's Marketing Tactics
'We are really clean when it comes to our relationships with physicians,' he said. He blamed the first-of-its-kind case on overzealous prosecutors trying 'to set up a new law' without going to the Legislature.
A subsidiary of Merck & Co has agreed to pay U.S. states $31 million to settle claims that it overcharged their Medicaid programs for an antidepressant it had sold at a discount to pharmacy companies, attorney generals from three states said on Wednesday.
The officials from Idaho, New York and Florida said Organon USA Inc offered the drug, Remeron, to nursing home pharmacies at a discount to encourage its use over competitors. At the same time, the company reported the full cost of the drug when seeking reimbursements from state Medicaid programs, the states claimed.
New Jersey-based Organon, which did not admit any wrongdoing, also was accused of improperly promoting use of the drug by children and teens.
The agreement, which includes Washington, D.C., and every state besides Arizona, settled whistleblower lawsuits filed in 2007 in federal courts in Massachusetts and Texas.
Organon also allegedly offered kickbacks to nursing home pharmacies to encourage use of the Remeron antidepressant. The drug maker also allegedly promoted the medicine for uses not approved by the FDA. The marketing included targeting children and teenagers, according to a statement from New York Attorney General Eric Schneiderman.
We try never to forget that medicine is for the people. It is not for the profits. The profits follow ,and if we have remembered that, they have never failed to appear.
In summary, Vioxx (rofecoxib, Merck) a Cox-2 inhibitor non-steroidal anti-inflammatory drug used for pain, and touted for its ostensibly low risk of gastrointestinal side-effects, was withdrawn from the market in 2004 because of its cardiac risks. The Vioxx case is flush with examples of how the company used deception to market a very profitable drug without regard to its risks to patients.
Thomas H. Faria, who resigned in March as president and chief executive officer of Sheffield Pharmaceuticals, pleaded guilty in U.S. District Court Tuesday to a felony violation of the Clean Water Act for knowingly discharging untreated industrial wastewater to the New London sewage treatment plant from 1986 to 2011.
Faria pleaded guilty to one count of knowingly violating, or causing to be violated, the Clean Water Act, an offense that carries a maximum penalty of three years of imprisonment and a fine of not less than $5,000 but not more than $50,000 per day of the violation.
The environmental impact of the violation over a 25-year-period is unknown, though Special Assistant U.S. Attorney Peter Kenyon from the Environmental Protection Agency said the EPA is unaware of any fish kills or direct harm suffered by humans.
'The possibility of impact from this type of discharge certainly exists,' Kenyon said during a conference call Tuesday.
Drugmakers Takeda Pharmaceutical Co. and Eli Lilly and Co. promised to appeal an award of $9 billion in punitive damages — one of the largest in US history — after a federal jury found they had concealed the cancer risks for their type 2 diabetes drug pioglitazone (Actos).
In addition, the jury ordered the payment of $1.475 million in compensatory damages.
Pioglitazone is associated with an increased risk for bladder cancer among persons with type 2 diabetes, according to a 2012 study in BMJ, as reported by Medscape Medical News. The US Food and Drug Administration in 2011 updated the pioglitazone label to warn against starting the drug in patients with active bladder cancer and to use caution if starting it in patients with a prior history of bladder cancer,...
attorney Mark Lanier said Takeda officials intentionally destroyed documents about the drug.
US District Judge Rebecca Doherty agreed and penalized the company, telling jurors they could infer that the files may have supported Allen's claims that the company wrongfully concealed the medication's health risks. 'The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing,' Doherty wrote in a January ruling.
In her ruling, Doherty said the original $9 billion damages award was 'excessive' and violated the companies' constitutional rights to due process.
She ordered Takeda to pay $27.6 million and Eli Lilly to pay $9.2 million for a total of $36.8 million. Doherty said that, while far smaller than the jury's original award, the reduced punitive damages were still 'large enough to accomplish the jury's clear aim: to send a message to the defendants that their wrongdoing must stop...'>
The companies also had sought a new trial, arguing that the court had made prejudicial rulings on evidence and jury instructions that tainted the trial's outcome.
Doherty rejected that request Monday, writing that the evidence during the trial showed that the companies 'disregarded, denied, obfuscated and concealed' for more than a decade that Actos could increase patients' risk for bladder cancer.
Teva Pharmaceutical Industries Ltd. has agreed to pay more than $27.6 million to settle state and federal allegations that it induced Chicago psychiatrist Michael Reinstein to overprescribe clozapine, a powerful antipsychotic drug.
Reinstein has twice figured into ProPublica investigations.
Four years ago, ProPublica and the Chicago Tribune spotlighted Reinstein's prescribing pattern, finding that in 2007 he had prescribed more clozapine to patients in Medicaid's Illinois program than all of the doctors in the Medicaid programs of Texas, Florida and North Carolina combined. At least three of Reinstein's patients died of clozapine intoxication. At that time, Reinstein defended his prescription record, arguing that clozapine is effective and underprescribed.
Then, last spring, ProPublica reported that Reinstein prescribed even more of the drug in Medicare's prescription drug program for seniors and the disabled. ProPublica cited Reinstein in an investigation about how Medicare fails to monitor problem prescribers,...
Illinois Attorney General Lisa Madigan and the U.S. Justice Department claimed that IVAX, a Teva Pharmaceuticals subsidiary, paid Reinstein to overprescribe clozapine to Medicare and Medicaid patients. Yesterday Teva agreed to pay almost $15.5 million to the federal government and more than $12.1 million to Illinois to settle those allegations out of court.
Teva spokeswoman Denise Bradley told Reuters that the settlement does not mean that the company has admitted any liability.
In November 2012, federal prosecutors also filed suit against Reinstein, alleging that IVAX hadpaid him $50,000 a year to work as a consultant, paid his nurse to promote the drug and funded a study at an affiliated research institute. After the payments, Reinstein began overprescribing clozapine. The company also allegedly paid for trips and entertainment for Reinstein and his friends.
a memo written by Holder in 1999, during his stint as deputy U.S. attorney general. The document, 'Bringing Criminal Charges Against Corporations,' urged prosecutors to take into account 'collateral consequences' when pursuing cases against companies, lest they topple and take the economy down with them. Holder also raised the possibility of deferring prosecution against corporations in an effort to spur greater cooperation and reforms—a policy, unsurprisingly, later supported by the Bush administration.
The attorney general angered many last year when he reiterated those concerns at a congressional hearing, admitting 'that the size of some of these institutions becomes so large that it does become difficult for us to prosecute' because of the potential nasty economic effects of a major company failure.
There’s some compelling evidence that the largest, most established companies are more likely to win leniency with a delayed or canceled prosecution: 58 percent of the companies awarded such deals are public firms listed on a U.S. stock exchange, while publicly traded firms make up just 6 percent of those against whom the Department of Justice obtained convictions.
Addenbrooke’s staff blame blood shortage on new eHospital
By CambridgeNews | Posted: November 05, 2014
By Freya Leng
Members of staff at Addenbrooke's [hospital, http://www.cuh.org.uk/addenbrookes-hospital] have voiced their concerns about the new IT system which has been blamed for a blood shortage.
Cambridge University Hospitals' eHospital went live on October 26 and is designed to improve the quality of care for patients by allowing clinicians and frontline staff to access patient information wherever they are, at the click of a button.
Enterprise resource planning (ERP) is a business management software—usually a suite of integrated applications—that a company can use to collect, store, manage and interpret data from many business activities
But since the launch, the News has been contacted by a senior member of staff at Addenbrooke's who said the new IT system was having "serious consequences" on the "operational running of the service".
In a letter, the staff member who does not want to be named [due to potential for retaliation - ed.], said: "The hospital has very little blood available due to transfusion lab technical failures. Truth - the new IT system is responsible."
The letter also states the impact the shortage of blood has had on the hospital including the cancellation of all elective surgery until November 8 as well as impacting on any procedure that holds a risk of blood transfusion and organ transplantation.
"I believe sufficient risk has been placed upon all patients under care of Addenbrooke's," the staff member said. "Someone needs to be responsible for the implementation of the new IT system."
The News also understands the whole system went down for six hours at the weekend with staff reverting back to paper and all major trauma cases diverted elsewhere.
A doctor, who also did not want to be named, said the wifi system which supports all the ward rounds is "unfit for purpose" and is leading to gross inefficiency.
"The general feeling on the ground is that they could not have implemented the system any worse than they have done and without any doubt it has already significantly affected patient care." they said.
A CUH spokesman said: "eHospital gives our staff more time with patients at the bedside, many of whom are frail, elderly and have complex conditions.
"However, unlike banks, shops or travel agents, we cannot close our doors or stop our services to the hundreds of thousands of people we treat every year. So it was always going to be a challenge to implement such a massive change.
"Pathology was affected early last week, which led to a brief reduction in the number of tests, but we are increasingly operating as normal. We did carry out a successful 're-boot' of the system early on Sunday morning.
"The much bigger challenge we face is that the Trust is incredibly busy and we have limited numbers of beds available, and which need to be kept free for emergency cases. Operations will continue to be rescheduled until the community care for those who no longer need a hospital bed is in place. We do sympathise with the frustration that people feel and apologise for the delay they are experiencing."
has been using the [controversial, unpublished] data to talk up Provenge. 'We’re clearly within shooting range,' Gold told analysts at a JP Morgan investor conference in January. 'Sometimes I use a football analogy where we are on the 10-yard line and we are in the red zone, and we need to punch it in the end zone right now.'
Dendreon threw a celebratory cocktail party Tuesday night at a Chicago hotel just off the Miracle Mile. CEO Mitch Gold was beaming as he slapped backs, shook hands and hugged employees, investors and supporters.
Dendreon said it has filed for bankruptcy protection as part of a plan to restructure $620 million in debt, a move likely to effectively wipe out the value of its common stock.
The biotechnology company, once Seattle’s largest, filed a voluntary Chapter 11 bankruptcy petition Monday in Delaware.
Brett Ingersoll, co-head of private equity at Cerberus, called the Caritas acquisition 'a big win for the hard-working communities of Greater Boston.'’ Ingersoll said the new owners 'plan to create jobs, expand local tax bases, and provide world-class health care facilities.'
'Cerberus is pleased to be making a long-term investment that will help ensure the viability and future success of the Caritas Christi health care system,' said W. Brett Ingersoll, co-director of private equity at Cerberus in a statement. 'Caritas is the region's largest community hospital network, and our investment will give physicians, nurses, and other health professionals the additional tools they need to deliver world-class care to patients in the communities they serve.'
'The business plan, the strategy, or whatever you want to call it, is all about keeping care locally,' he said. 'If we improve the facilities, improve the infrastructure, make it so that our very own patients want to stay in our hospitals, that’s the business plan.'
The new holding company 'will continue to promote the public interest after this transaction,' Lisa Gray, Cerberus general counsel executive and a Steward board member, told the council.
Once finalized, the sale will ensure the future of our system, the jobs of our employees, and the pensions of our retirees.
In a statement today, interim CEO John Kastanis said the hospital's announcement is 'the culmination of an exhaustive process to find a capital partner who is committed to our mission, our employees and physicians, and the communities we serve.'
'We have found the partner in Steward,' Katsanis said. 'Steward is a community-based hospital system with tremendous resources that will enable us to grow and continue to provide world-class health care for generations to come.'
[Attorney General Martha] Coakley imposed multiple conditions on the deal that are meant to safeguard patients and employees of the financially struggling hospitals. They included a guarantee that Boston-based Steward will not sell either one for at least five years, that it will keep making capital improvements after five years,...
agreed to a 10-year “no close’’ period for both hospitals, though the deals included clauses that would allow Steward to close the hospitals under certain conditions in the last three years if financial targets aren’t met.
Steward Health Care System said Thursday that it would close Quincy Medical Center and displace nearly 700 workers after the long-struggling hospital finally succumbed to the intense competition for patients south of Boston.The shutdown, scheduled to be completed by the end the year, marks the biggest hospital closing in the state in at least a decade and the first failure for Steward, the for-profit company that promised to reinvent community health care when it entered the Massachusetts market four years ago.
'We have just been notified about this decision and are currently reviewing it in the context of Steward’s legal obligations,' said Brad Puffer, a spokesman for Attorney General Martha Coakley.
When Steward bought the 196-bed Quincy hospital in a bankruptcy auction in 2011, it signed an agreement with Coakley that included a 10-year 'No Close Period' requiring that it 'maintain an acute care hospital in Quincy providing at least the same scope of services as Quincy Medical Center currently provides.'
Steward could close Quincy Medical in the last three-and-a-half years of that 10-year period if it could show the hospital 'experienced two consecutive fiscal years of negative operating margins' and provide the state’s Department of Public Health with 'at least 18 months prior written notice of its intent to close,' according to the agreement.
A Steward spokeswoman declined to comment when asked about the no-close clause last night.
Bug in MetaVision ICU system potentially catastrophic
Written by Kate McDonald on 27 October 2014.
A bug in the MetaVision intensive care software package being rolled out in several Brisbane hospitals has been identified as having the potential to seriously harm or even kill patients, several media outlets are reporting.
Fairfax's The Brisbane Times reported that a risk assessment by the Metro North Hospital and Health Service - which covers Brisbane's Prince Charles and Royal Brisbane and Women's (RBWH) hospitals - had found potentially catastrophic problems with prescription errors caused by the system that had a 60 to 90 per cent likelihood of causing a patient death.
MetaVision, from US vendor iMDsoft, is one of the few specialist critical care software packages on the market. It is able to capture information from medical devices and contains a full medical record specific to ICU patients.
... It also contains medications management and decision support, and is able to interface with the complex IV infusion pumps used to administer medications to patients in intensive care.
The ABC [Australian Broadcasting Company] reported that according to the risk assessment report, “monitoring of patient records by pharmacists has revealed several potentially serious prescription errors specifically caused by the system”.
"Large volume prescriptions and high acuity of patients overlayed [sic] with functional risks of the system increases the likelihood of a SAC 1 (serious harm or death) event.
"There is no record of robust regression or functional testing at vendor, Queensland Health corporate or facility level."
MetaVision has been rolled out in the ICUs at the Canberra and Calvary hospitals in the ACT, and at the Gold Coast, Prince Charles, Townsville, Rockhampton, Cairns and Logan hospitals in Queensland, where it has been installed for over a year.
It went live at Brisbane's Royal Children's in June, RBWH in September and at Princess Alexandra Hospital (PAH) just last week.
It is live at the Sydney Adventist Hospital and has also been chosen for a statewide roll-out in all ICUs in NSW.
MDsoft issued a statement late on Monday saying that the problem was unique to the version implemented at Queensland Heath and does not affect any other installations in Australia.
"Late last week, certain clinicians from Queensland Heath highlighted potential risks as a result of prescribing with the MetaVision clinical information system," iMDsoft's director of marketing, Anne Belkin, said.
"iMDsoft is aware of this issue, and has already provided a solution to Queensland Heath. The software fix has been in testing at the site for several weeks and will be implemented in the near future.
"The risks highlighted by the report were originally identified during testing and, with close cooperation between iMDsoft and the clinicians at the Hospital and Health Service sites, a mitigation plan was immediately put into effect. ... [The Brisbane Times] said the system has been manually over-ridden with medical charts [presumably the electronic charts - ed.] being reviewed daily by ICU specialists.
"The underlying risk is unique to the version implemented at Queensland Heath, and does not exist in any prior or subsequent releases for Australia. MetaVision is used at more than three hundred sites worldwide and is regulated by stringent international standards to ensure patient safety."
iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements.
Brent Richards, director of intensive care at the Gold Coast Hospital and then chairman of Queensland's Statewide Intensive Care Clinical Network, told Pulse+IT last year that the system delivered improvements in workflow and safety.
“ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said. “You want to capture all of that data including the data from the equipment interfaces, which is transferred minutely in MetaVision.
“Giving drugs is a lot more complex because ICU patients frequently have numerous infusions, and there is frequent real-time management of infusions – titrating medication infusions is normal in ICU – and the system has got to be able to capture it.”
From: Silverstein,ScotRe: http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=2127:bug-in-metavision-icu-system-potentially-catastrophic
Sent: Friday, November 07, 2014 9:58 AM
To: Kate McDonald
Subject: Re: Bug in MetaVision ICU system potentially catastrophic
I hope you are well. My Australian colleagues alerted me to your article on the Metavision ICU flaws.
The excuse that:
... “ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said.
rings incredibly hollow.
If an ICU is so complex, the most stringent IT testing is indicated BEFORE go-live on actual patients. If this were an aircraft or nuclear energy facility, one might now have a smoldering ruin or a Chernobyl (or Three Mile Island in the U.S., http://en.wikipedia.org/wiki/Three_Mile_Island_accident) radiation cloud.
Live patient environments, especially with the sickest in an ICU, are not proper software beta testing and debugging environments.
This is why in the U.S. I call for mandatory and strict quality and safety regulation of healthcare IT that will be employed on patients, much as software is regulated in other mission-critical and life-critical industries.
The health IT industry has for decades been given an extraordinary regulatory accommodation - that is, little to no regulation - and this can, and has, harmed and killed patients.
Please consider this letter suitable for publication. I addressed some of these issues in my keynote at HISA 2012 in Sydney.
Introduction: The Issues Ignored by Discusisons of Health Care Reform After the failed attempt to "repeal and replace" the Affor...