Falsification of Data: Truth or Consequences


by Peggy Salvatore and Terry McGinn

This article is cross-posted at www.workingwithsmes.com


Sometimes expert knowledge isn’t really knowledge at all. In fact, if your data sounds too good to be true, it just might be.  Sadly, for reasons of human sloth, greed or carelessness, sometimes the experts who supply your data are giving you bad information – and they know it.

In Finding Your SMEs, we discuss times when you may be dealing with conflicting expertise or when you may be asked to ignore some information and favor other information in your documentation to please a stakeholder. In those cases, you aren’t dealing in bad data. Rather, you are dealing with differences of opinion.

That’s an honest debate of the relevant facts.

Falsifying data to purposefully mislead someone is different than simple disagreement among experts.

When you are dealing with falsified data, there are no facts. There is no honest debate. There is only an intent to deceive. In regulated industries that depend on quality data to remain in legal compliance, falsified data can have many bad outcomes including products that are substandard, dangerous or deadly. Your best defense is to know your regulations and how to work with them because, remember, you can be guilty simply by omissions.

Remember Volkswagen? What About Your Drugs?

In 2015, the U.S. Environmental Protection Agency discovered that many VW cars were outfitted with software programmed to falsify data during emissions testing showing the cars met carbon dioxide emission standards. The brand suffered substantial damage and the company was exposed to up to $18 billion in fines when it was discovered the cars actually emitted up to 40 times the allowable amount. This attempt to defraud the public resulted in massive car recalls and a loss of company credibility along with profits.

Money lost. Reputation lost. Environment damaged.

In biopharmaceuticals, clinical trial data is the stuff upon which the Food and Drug Administration makes decisions about the safety and efficacy of pharmaceutical products. Does data get falsified there, too? Unfortunately, yes!

A 2001 study showed that falsification of scientific data used in FDA evaluations of experimental drugs was not uncommon, and it ranged from falsifying the identities of clinical trial subjects and their physical exam results to creating duplicate records to achieve the desired number of trial subjects.

It still happens today.

Just a few weeks ago, a Kyoto University research group headed by Nobel laureate Shinya Yamanaka was found guilty of fabricating all six main data figures in a study published in Stem Cell Reports. The study claimed it had modelled the blood-brain barrier in vitro using pluripotent stem (iPS) cells. Yamanaka, who won the 2012 Nobel Prize in physiology or medicine for discovering iPS cells, reportedly was going to donate his salary to the university as a mea culpa but the damage to his reputation will live beyond his paycheck.

Bad data can hurt – or even kill- patients and it exposes the biopharma research companies who rely on quality data to potentially billions of dollars in fines and, at the end of the day, the delay or loss of up to a billion dollars in research and development for a product that can’t be supported by strong, reliable data sets.

Is Your Data Subject to Tampering?

One of the ways to ensure that your data is valid is to have strong processes in place for data collection and auditing. Long before an FDA or compliance inspector finds a problem with your product or process, you can lock down your documentation with well-written and faithfully executed standard operating procedures.

By taking some strong action today, you can implement steps to avoid harm to your brand reputation, delayed or denied product approval, heavy fines, jail time and, of course, harm to patients.

If you would like to discuss your process for developing and implementing standard operating procedures, write to us at workingwithsmes@gmail.com and schedule a no-obligation appointment for a review of your organization’s data integrity vulnerabilities.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection.

Posted in biopharmaceutical training, biotechnology, clinical trials, expert knowledge, health IT training, standard operating procedures, training | Tagged , , | Leave a comment

Health Wonk Review: Ideas of March Edition

Direct from David E. Williams’ Health Business Blog, the Ideas of March. Enjoy the wonkery, and check out the video podcast CareTalk interview below with David and CareCentrix CEO John Driscoll. 

Beware the Ides of March” –Soothsayer to Julius Caesar
Fear not the Ideas of March” –Health Business Blog to the wonkosphere

If you see something say something

Your friendly neighborhood drug dealer

Count on Drug Channels to make sense of even the most convoluted pharmacy business models –and convoluted they are. This time the topic is the emerging trend of point-of-sale (POS) rebates. Did you know that many pharmacy benefit plans act like reverse insurance, with the sickest members subsidizing the healthiest? POS rebates start to right this wrong and bring forth uncomfortable questions such as: Where have the rebates been going until now?

Crocodile tears

Managed Care Matters shares its perspective that the Administration’s efforts to undermine the ACA have yielded bitter fruit on the marketplaces. Some premiums are up by 30% and meanwhile Congress is doing little or nothing.

Two years ago you couldn’t read the news without hearing about the disastrous premium increases due to “Obamacare,” but the media is silent now.

So what’s going on? Our blogger has a theory: The media is being manipulated and chasing bright, shiny objects.

Skimpy is as skimpy does

InsureBlog likes CMS’s proposal to restore the maximum policy length of short-term medical plans to 12 months from three. That’s even though some news outlets call the plans “skimpy” and some healthcare policy analysts consider such plans to be leeches on Obamacare, because they may siphon the healthiest people out of the marketplace risk pool and drive up premiums.

Location location location

When my son was a toddler, we trained him to say “location location location” when asked, ‘what are the three most important things about real estate?’ I still remember him driving a realtor crazy when one tried to pitch us on a house we didn’t like.

Now, Workers Comp Insider has decided that location is destiny in healthcare, too, declaring ‘It’s the Zip Code Stupid.’ Insider cites a recent JAMA Internal Medicine study that shows geography is “the biggest X-Factor in today’s American Hellzapoppin version of healthcare.”

Location: Wonk zone

The Hospital Leader (not to be confused with the Dear Leader) helpfully explains that “We need creative solutions” really means “the problem we are trying to solve has no answer.” Case study: Hospitals, hospice and SNFs – The big deceit.

A pending bill seeks to establish a state-based individual mandate in New Jersey. But a provision targeting employees of small businesses could inhibit Association Health Plans from selling insurance that does not comply with small group rules. Xpostfactoid explains.

Who knew? Health Care Renewal informs us that the ostensibly libertarian Washington Legal Foundation has become a front for healthcare corporate leaders –and leaders from other fields— to operate with impunity. The foundation’s campaign to abolish the Responsible Corporate Officer Doctrine failed, but the damage was done. (Hat tip to Health Care Renewal for anticipating today’s theme by including “methinks” in its cover note.)

Local talent

The Health Business Blog is now a teenager. I ran the annual round-up of favorite posts by month.

CareCentrix CEO John Driscoll and I rant and rave about Amazon and innovation in the latest monthly episode of #CareTalk.

Singing from the himmnal

Health System Ed shares results from the 2018 US HIMSS Leadership and Workforce Survey, a survey of providers and vendors.

Top themes: privacy and security, process improvement and workflow, data analytics, business intelligence to inform clinical decision-making remain top of mind. 

Well that’s it for the Ideas of March edition. Watch your back today!

By healthcare business consultant David E. Williams, president of Health Business Group.

Posted in biotechnology, consumer health apps, electronic patient records, health economics, health insurance, health IT, health policy, health reform, healthcare marketing | Leave a comment

2018 HIMSS Survey of Priorities for Health Information and Technology

Last week was the most important annual convention for health information technology, HIMSS 2018. The Health Information Management Systems Society (HIMSS) provides a forum for thought leaders and a venue for innovative products.

The 2018 U.S. HIMSS Leadership and Workforce Survey provides some insights about the state of health IT today and where its efforts will be focused for the next 12 months. With input from 369 hospital/health system and vendor respondents, the survey revealed that privacy and security, process improvement and workflow as well as data analytics and business intelligence to inform clinical decision-making remain top of mind.

For a glimpse of the 2018 priorities of the HIMSS respondents, this chart shows the Top 10 concerns of hospital leaders and the correlating priorities of the vendors who serve them. While there tends to be agreement about the top 10 issues facing health IT today, vendors and their customers do not always have alignment about their relative importance.


HIMSS Priorities




A Saturation Point

One of the most telling discrepancies between hospital and vendor respondents was the fact that hospitals overwhelmingly either anticipated stagnation or reduction in hiring in 2018 while vendors are still showing aggressive hiring practices. Vendors may be responding to last year’s demand and this survey indicates a need for them to adjust their projections to align with their customers.


HIMSS workforce

This trend may show a saturation point for hospitals regarding how much more change and expense they are currently willing to incur to play the expanding health information technology game to the level that the government, innovators and vendors would like to push them.

Willingness is only part of the equation. The next generation of health information products in development will move information and technology to further integration and greater utility for patients, providers and payers. This trend is a juggernaut that will take both hospital and vendors with it in the next few years. Guaranteed.


Posted in consumer health apps, electronic patient records, health economics, health IT, health IT training, health policy, healthcare change management | Leave a comment

Let’s Talk BioPharma Training: 3 Tips for Creating Transparent SOPs


By Peggy Salvatore and Terry McGinn

Each company in a regulated industry is required to follow written procedures.  The written procedure describes how steps or tasks are to be followed to achieve the desired outcome or result.  Having these steps identified permits the distant or precise way to achieve the end of your process or practice. 

Knowing the critical nature of having written procedures, your standard operating procedures and best practices need to follow a few procedures of their own so you can replicate what you do across your organization.  In other words, your standard operating procedures need to be transparent and streamlined.

One of the many purposes of the SOP or best practice process is to ensure that the process flow can meet expectations. Done well, your standard process or procedure should result in a quality product or achieve the desired result every time.

Knowledgeable and trained  personnel must have the SOP available to follow because no matter how many years’ experience they may have, even experts get stuck for a variety of factors. In fact, some experts know their jobs so well that they think they can skip or modify steps, take shortcuts, or do it from memory. This is a red flag!

The SOP should be written in a logical process flow that will allow someone looking for the cause of a failure later can pinpoint where a difficulty arose. Reviewing the SOP with someone internally or externally who is checking or auditing your procedure should allow them to identify what and where things  went wrong.

When you have a point of failure, an examination of the SOP should indicate gaps or problems that can include one or more of a host of issues including materials, equipment, environment and much more. Often, a failure can point to the source of your complications by reading the SOP against practice.

A well-written procedure or best practice document will:

  1. Be written to describe the flow clearly to anyone trained on it
  2. Include every essential step without including extraneous steps or materials that can and should be accessed elsewhere
  3. Always be followed by everyone from the new hire to the veteran employee using the current SOP

Expect you will have changes to your SOPs on occasion. Expect you will need to review your documents periodically according to your SOP. And expect that when you have a clean, clear, streamlined SOP process that your errors should be few and easily identifiable.

To summarize, standard operating procedures and best practices need to follow procedures of their own so you can replicate what you do across your organization.  In other words, they need to be transparent. If they are the opposite of transparent – opaque – they are hard to follow and may result  in errors.

If you would like to talk to us about your SOP process, give us a call for a no-obligation preliminary review of your procedures.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection. To have a conversation about writing your standard operating procedures, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash

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Standard Operating Procedures and Accountability: Perfect Together



By Terry McGinn and Peggy Salvatore

We’ve been getting quite a bit of interest and feedback regarding our series on standard operating procedures, so we’ll continue writing about this topic this week.

After all, inherent in the word “expert” is the idea that something is done correctly. Correct procedures and best practices need to be captured and passed on. Sometimes, though, it seems the only people who care if the SOPs are followed are the experts who wrote them.

Truth is, everyone needs to care. Accountability right down to the last man or woman is absolutely the key essential ingredient in ensuring regulatory compliance.

Train for Accountability

Employees who are tasked with executing the many small, incremental steps are responsible only for their piece of the process. Sometimes in the laser-focus on one task, people may lose sight of the bigger picture. That bigger picture – a safe product going out the door – needs to be reinforced occasionally. Training usually steps in here for both reinforcement and correction. When that fails, the regulatory authorities will notice. Companies get slapped with government warnings and fines at a higher rate than the average person may realize. But if you are in a regulated industry, you know how often you are out of compliance.

Think about dialing the failure point back to its origin. The failure point is when the SOP is not correctly written, understood and applied.

Only then does the employee fail to perform to specifications.

Only then will training have to step in for often very expensive correction.

Only that will happen when an audit reveals you are out of compliance with your SOPs, and the Corrective and Preventative Actions (CAPAs) applied at that point of failure. That doesn’t need to happen.

In a perfect world, it should look like this:

Point of Success

If your current plant is not operating flawlessly as above, identify your points of failure:

  1. How many people are asked to retrain personnel after a deviation or equipment issue?
  2. How many SOPs do you have? Are they overwhelming or conflicting?
  3. Are they easy to understand and do they follow a logical, stepwise process?
  4. After a deviation, is the SOP reviewed?
  5. Are people observing the CAPAs?

And, the big question…

Do your employees feel responsible and accountable for performing their jobs according to the SOPs in place?

Employees feel empowered when they are able to follow well-written SOPs, and when they are acknowledged for contributing to a well-run organization. Points of failure cannot be business as usual. Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

Maybe that is worth repeating:

Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

And the road to audit hell is paved with regulatory non-compliance.

The Solution

Dial back your points of process failure to the source.

Ask yourself:

  • Are my SOPs well written?
  • Do my employees feel a sense of responsibility for performing to specifications?

If your answer to either of those questions is, “No” or “I don’t know”, give us a call.

We would be happy to speak with you.

Unlike some problems in the universe, the problem of poorly-written and executed SOPs can be solved. Let’s do it.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection. To have a conversation, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash

Posted in biopharmaceutical training, biotechnology, elearning, health IT training, training | Leave a comment

Health Wonk Review: Going for the Gold Edition

It’s February 15 … and a day too late for a Valentine Edition of Health Wonk Review this week. The good news? I’m all swept up in the Olympic spirit and ready to award some hardware to this week’s Health Wonk Review contributors.

No medal awarded.

Is the JPMorgan/Amazon/Berkshire Hathaway healthcare alliance the “worst idea ever?” Joe Paduda – over at Managed Care Matters – doesn’t think so. In fact, it’s not the proposal that’s getting low marks from Paduda.

In Media coverage of Amazon/Berkshire/JPMorgan misses the point. Paduda gives critics of – and coverage of – the healthcare alliance a thumbs down. He also speculates on some outcomes of the A/B/J alliance.

Meanwhile, David Harlow has a medal-worthy rundown of the Amazon/Berkshire/JPMorgan alliance and also Apple’s foray into personal health records. David asks, “Are they both less than they seem? What would it take for these announcements to really capture our attention?”

David shares his thoughts on what it will take for these behemoths to succeed in A tale of two tech titans hoping to help healthcare.

And speaking of behemoths and healthcare, in Anthem Insurance & Emergency Room Visits That Go Uncovered Louise Norris offers a great explainer about unexpected ER bills and a controversy over how insurers pay for trips to the ER.

Norris is, of course, writing about Anthem, which issued new rules in Georgia, Indiana, Missouri, and Kentucky in 2017 that shift the cost of ER visits to the patient if a review of the claim determines that the situation was not an emergency after all.

An infraction worthy of a DQ

At Health Care Renewal, Roy Poses brings us the tale of an Olympic-level assault on freedom of the press – one that rises to the level of not doping but perhaps dopiness.

In Free Press? Don’t Need No Stinkin’ Free Press – Center for Medicare and Medicaid Services (CMS) Tries to Intimidate Modern Healthcare Journalist, Poses tells the story of a ham-handed CMS attempt to bully (unsuccessfully) Modern Healthcare journalist Virgil Dickson into changing a January 23 story.

It’s a must-read.

Head-to-head action that will make you hit Instant Replay

This week’s submission from #CareTalk – Mr. Azar Goes to Washington – actually required me to tune in to a 10-minute discussion on YouTube. And I’ve gotta say I was both entertained and enlightened by the banter between David Williams (Health Business Group) and John Driscoll (CareCentrix) as they made predictions about the impact of newly appointed HHS Secretary Alex Azar.

Come for the zingers. Stay for the Lightning Round.

The American ‘judge’ scores Peru

International flavor is, of course, what the Olympics is all about – and Jason Shafrin definitely fills the bill with his fascinating look at Health care in Peru.

Let’s just say that if health systems competed for medals, Peru would have a tough time overcoming its apparent underdog status. Spoiler: life expectancy in Peru is ranked 126 out of 224 countries. (Before 2007, more than 60 percent of the population had no health insurance coverage.)

A medal for members of Congress?

Over at ACASignups.net, Charles Gaba has the dirt on efforts by Senate Democrats to help stabilize the Affordable Care Act by pushing for increased ACA subsidies. Should Patty Murray get a medal for her efforts? Not sure, but Charles should definitely get a Gold for his tireless work to deliver health reform updates and analysis to us all.

But wait. Tom Lynch at Workers’ Comp Insider is also awarding high marks to * gasp * legislators in DC. In Who’d A Thunk It? Something Good Out Of DC!, Lynch explains how “in a rare Washington Kumbaya moment,” legislators dedicated a little pork to “poor people who are aging and sick: America’s Dual Eligibles.”

“Finally, this Congress has done something that will benefit our most vulnerable citizens. Let’s hope it’s not a one-off,” Lynch writes. (And we concur.)

Something else we can all cheer for

And speaking of news that gives us hope and inspiration … Henry Stern at Insureblog had a post that elicited a cheer from Yours Truly this week.

In Something different (and potentially quite helpful), Stern adds his voice to an apparently growing movement intended to give us all more coverage when we go to the hospital. I won’t spoil the post for you, but I will drink to Henry’s sentiment with a wink and a “Bottoms up!”

A recap from the podium. No, not THAT podium.

OK. So it wasn’t a medalist podium somewhere in South Korea, but Andrew Sprung did make it to that OTHER important convo in 2018 – Health Action 2018, Families USA’s annual confab of healthcare activists.

Andrew reports that the event was “largely devoted to taking the measure of the political power somewhat miraculously tapped by a wave grassroots passion and action that staved off repeal – and groping toward a path by which Democrats can build on or move beyond the ACA in years ahead.”

His recap of the conference – Democrats and activists prepare health care offensive – examines what kinds of next steps – or false starts – the conference conversations pointed toward.

And finally – a story of indomitable spirit

The thrill of victory in defeating ACA repeal. The agony of Obamacare sabotage. It’s a great story.

Also great? A story on this site: Shawn Dhanak’s account of four consumers who are ignoring news of health reform setbacks and continuing to put their faith in the ACA’s protections. They’re still enrolling – like their lives depend on it.

So put on your giant foam finger and join me in waving a little American flag for this week’s contributors.

You stuck that landing!

Source: https://www.healthinsurance.org/blog/2018/02/15/health-wonk-review-for-february-15-2018/
Follow us: @EyeOnInsurance on Twitter | healthinsurance.org on Facebook

Posted in biotechnology, consumer health apps, electronic patient records, health economics, health insurance, health IT, health policy, health reform | Leave a comment

Fresh Health Wonk Review for a Fresh New Year

n-GENIUS-628x314Joe Paduda gets the year started with his  fresh edition of Health Wonk Review: Ring in the New year with the latest and greatest…  posted at Managed Care Matters.

Here’s Joe:

“Blog posts!

Health Wonk Review returns to the inter-webs after a holiday hiatus. Refreshed, renewed, and revitalized, we bring you the best from the brightest!”

Thanks much for kicking off the new year, Joe!

Posted in biotechnology, health economics, health insurance, health policy, health reform, healthcare marketing, pharmaceutical marketing, pharmaceutical sales | Leave a comment

Late Days of the Empire Edition of Health Wonk Review

aaron-burden-97663From Andrew Sprung  of xpostfactoid: We’re addled on many fronts here in Trumpville, and this week’s Health Wonk Review reflects that. We have snapshots of a country that continues to trail its peers in population health measures; an opioid vendor looking to short-circuit potential tobacco industry-level liability; an individual market for health insurance offering unaffordable plans to many of the unsubsidized, and freakish bargains to some of the subsidized; and, for a little futuristic relief, a human resources tech vendor that may chain healthcare data to a block, where it shall remain unaltered forever and ever.

Posted in health economics, health insurance, health IT, health policy, health reform | Leave a comment

A Conversation at #CareTalk and the Short and Sweet Disaster Edition of Health Wonk Review

David WilliamsLet’s talk.

In this month’s episode of #CareTalk, CareCentrix CEO John Driscoll and your host, David Williams from Health Business Group chat about the recent hurricanes that have impacted the US and what can be done to protect vulnerable populations.

And while you are there, check out Health Business Blog David Williams’ Disaster Edition of Health Wonk Review this week. It’s short. It’s full of big pictures. And to paraphrase David, it features “quality over quantity.”

Thank you to David and the faithful HWR Class of 2017 who populated this edition.

Posted in health economics, health insurance, health policy, health reform | Leave a comment

Health Wonk Review: Pink Edition

msabc-logoMother nature and man’s inhumanity to man have given us no shortage of opportunities to reach out and help our fellow citizens here in the US in the last few weeks where hurricanes, fires and terrorism have taken an ugly toll on life, property and any sense of security you might have enjoyed.

So, while you have your wallet and your heart open, here’s a reminder that it is Breast Cancer Awareness month at Health Wonk Review, too.

Click here for the Pink Edition hosted by the inimitable Hank Stern at InsureBlog where you can find out how to sponsor Hank’s team on his walk to raise money to fight breast cancer.

‘Til next time, stay safe out there.

AAtjntrFires in Wine Country north of San Francisco continue to burn out of control as of this writing.

Photo by Nick Giblin/DroneBase via AP


Posted in health economics, health insurance, health policy, health reform | Leave a comment