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The FDA and eMR Regulation?

One HIT Futurist’s Opinion

By Staff Reporters

A few years ago, Shahid N. Shah wrote that the FDA should be paying closer attention to healthcare IT systems and consider regulating those systems; in other words – regulating them the same as any other drug, medical device or foodstuff.

After all, some healthcare IT systems can kill just as easily as inappropriate medical care.

Link: http://www.healthcareguy.com/2010/02/24/thank-goodness-the-fda-could-start-regulating-healthcare-it-systems/

Our View

We agree that hospital IT systems and eMRs can, do, and will kill when not used or implemented properly.

And, it’s a shame that we may need the government to improve quality; but perhaps the fear of regulation will do the trick. In fact, we’ve also warned of similar adverse unintended consequences of eMRs and related HIT systems, previously on this ME-P.

Link: https://healthcarefinancials.wordpress.com/2009/12/23/will-electronic-records-raise-the-legal-standard-of-care-and-increase-malpractice-risk/#comments

About Shahid Shah

Shahid is CEO of Netspective, a Java/.NET consultancy that specializes in healthcare IT with an emphasis on e-health, EMRs, data integration, and legacy modernization. He is also a valued thought-leader for the ME-P, who will be contributing the HIT chapter for the third edition of our best selling book: www.BusinessofMedicalPractice.com to be released later this Spring.


And so, your thoughts and comments on this ME-Pare appreciated. Should eMRs be regulated by the FDA? Does the FDA need to put even more on its plate and has it done a good job until now? Do we really need more governmental intervention in healthcare?

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Encrypt or De-identify PHI

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Which One Just Might Work?

[By Darrell K. Pruitt; DDS]pruitt

The United States’ advancement in Healthcare Information Technology, which has the potential to lead to wonderful money-saving cures through research using trustworthy interoperable health records, is currently stopped cold by patient security problems that are only getting worse. Our lawmakers cannot get around the security obstacle without resorting to authoritarian means using CMS’s power to withhold providers’ discounted payments and threats of obscene fines from the HHS and the FTC. History shows that tyranny is not tolerated well in this part of the world. Lawmakers can get their butts voted smooth out of office in my neighborhood.


Here is something nobody mentions: Despite the current hope in a thick, political fantasy called HITECH, encryption of patients’ Protected Health Information [PHI] is a non-starter in the land of the free. Everyone knows that resourceful, cynical Americans will simply never trust encryption to protect their secrets, and will reliably withhold important information from their eMRs – one way or another. Doctors as well as patients can be expected to go out of their way to sabotage technology they fear. We all intuitively know this is true, don’t we? We aren’t so naïve to think all the players will happily play by the rules, are we? And I think we can all agree that an untrustworthy digital health record in an emergency room is worse than no patient information at all. Security is a grand problem with eMRs that started with HIPAA changes in 2003 that made eHRs so slippery. And the problem is clearly not being resolved. Not yet.

Public Lacks Trust 

Regardless of the campaign donations which follow him, there is nothing Newt Gingrich and his entrepreneurial friends in high places can do about the public’s lack of trust in encryption. It gets worse: Encryption hasn’t a chance of isolating PHI from dishonest employees in doctors’ offices, and slippery digital patient data can be moved soo easily. Everyone knows that as well, don’t they? It is estimated that two-thirds of the identities stolen in the nation are lifted from doctors’ offices. That’s us, Doc. HIPAA is not only irrelevant, it is an expensive distraction – it gives future ID theft victims a false sense of security.

HIPAA Approved 

De-identifying digital records is not mentioned in HITECH as a HIPAA-approved method of security. Yet it is the ONLY solution that promises to be even more secure than paper records. Because of heavy stakeholder stakes in hospital care, it will take longer for CEO-types to embrace patient-friendly de-identification. Other than identifiers such as names, social security numbers, birthdates, addresses and other items that have street value, NOBODY cares what is in a dental record. I actually think this opens a tremendous opportunity for someone courageous in the Texas Dental Association to discuss the feasibility of de-identification of dental records. Otherwise, instead of leading the nation in solving security problems, the TDA will look just as stupid as the ADA.

Encryption would also provide a dangerous false sense of security in eMRs – that is if it had a chance in the marketplace. But encryption will never go far because consumers simply won’t buy it. That is a marketplace fact that stoically optimistic HIT stakeholders are trying hard to avoid. They also know they are running out of time. Deadlines are quickly approaching for both HIPAA and the Red Flags Rule that providers are far from prepared for.

Former Attorney Speaks 

Bill Lappen, a former attorney and author of the ad I copied below, as well as a partner with his brother David in the de-identified health record venture says: “Since no identifying information is ever entered, a hacker can’t determine whose information is shown.”

So in addition to protecting one’s practice against dishonest or vindictive employees, de-identification of dental records would make hacking a dentist’s computer a complete waste of time, and hackers wouldn’t endanger dental patients and bankrupt dentists.

My Confidence 

I confidently tell you that soon, someone smart will come upon the unprecedented idea that the ultimate answer to our security problem in healthcare will be de-identification of medical records, not encryption. De-identification allows a compromise of privacy for only a miniscule percentage of physicians’ patients. We cannot allow that to stand in the way of better health for everyone else. Those special cases are so few that I am confident that they can be dealt with individually. We simply must move forward. I’ll have to retire some day. I may need help from Medicare.

Encryption gives us only danger and protects nobody but a thief with a key.


We’ve wasted enough time on HITECH and HIPAA, as well as CCHIT. It’s time to say no to stakeholders and pay attention to patients’ needs instead of those who would needlessly increase the cost of their care. Stimulus money attracts cockroaches.

In the name of Hippocrates, disregard the tainted HIPAA mandate. It is dangerous, and especially absurd in dentistry.

Link: http://www.theopenpress.com/index.php?a=press&id=58568

Life-Saving Patient Information can be Online, Anonymous and Usable

Published on: September 26th, 2009 12:19am

By: blappen

Los Angeles, CA (OPENPRESS) September 26, 2009 — Hospital Emergency Rooms need instant access to patient medical information. Allergic reactions and dangerous drug interactions can be deadly. Time is critical. Until now, privacy was a large concern. Two brothers, who have developed medical software over the past 15 years, think they have a simple first step towards moving patient information on to the internet.

“The ER doesn’t need to look up the information by patient name” said Bill Lappen, a former attorney. “We have implemented secure systems in the past, but no matter how secure we make the site, we have to assume that it will be hacked” added David Lappen, a computer design engineer from Stanford. “But providing instant access to life-saving information is too important to ignore”, he added. To protect patient privacy, their system does not know to whom the medical information belongs. Since the person’s identifying information is never on the system, it can’t be stolen. “By enabling anonymous entry, we have protected people’s privacy while allowing them to put their life-saving information in a place where it can be instantly accessed when needed”, added Bill Lappen.

www.AMCC.me is the public service website they created. It allows anyone to enter medical information anonymously. The site provides a random ID which the user carries in his/her wallet. For someone to see that user’s medical information, they merely enter the ID into the site. Unless the user has given them their ID, the information shown is meaningless. That same information, when associated with a patient, can save their life.

Since no identifying information is ever entered, a hacker can’t determine whose information is shown. “Secure patient-controlled Electronic Medical Records are now available on the internet” said David Lappen. A sample ID has been set up on the site to allow users to evaluate the concept before setting up their own free ID.


Bill Lappen


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Kelly Mclendon RHIA censors D. Kellus Pruitt DDS

By Darrell K. Pruitt; DDS

Dateline: 8.15.09


Dear Kelly Mclendon, Registered Health Information Administrator

You are beginning to make me feel insulted, and I will not have that. I just noticed that the last two comments I submitted to your Website, www.spacecoastmedicine.com, on August 9 and 10, are still “awaiting moderation.”


(For clarity, the comments which scared Mr. Mclendon are copied below) 

Over five days have passed, and I want you, your readers and my readers to know that I spent a lot of time preparing those two pieces exclusively for you at your invitation for comments. You are as sincere as I am, aren’t you? 

When I’ve caught others in the squeeze you might be experiencing, several have pleaded that the censorship was an innocent oversight, and did the right thing immediately by posting everything I send them (include this comment, please). And then again, there are a few slow-learning, command-and-control types who think they cam still somehow control the content of their Websites. Like you, Kelly, an anonymous dentalblogs.com editor whom I call “Nancy” by default, also informed me that my comments were awaiting indefinite moderation. What a foolish, rookie mistake that proved to be. For example, if you google “dentalblogs.com,” my article “Dentalblogs.com hates D. Kellus Pruitt DDS” is their 4th hit. It seems to be very popular. 

How’s this for the title of a comment that should make it to your first page by Monday: “Kelly Mclendon RHIA censors D. Kellus Pruitt DDS”? Please, no phone calls. 

D. Kellus Pruitt; DDS 

Dateline 8.9.09 

I’m sure physicians’ businesses are no different than dentists’ when it comes to the liability of data breaches – especially considering the giddy, mindless momentum of HITECH-empowered HIPAA. If a computer is stolen in a burglary, compromised by a dishonest employee who sells IDs on the side, or otherwise hacked, and the dentist reports the tragedy according to the letter of the law, it inevitably means bankruptcy even before the feel-good fines are levied by HHS (HIPAA) and the FTC (Red Flags Rule) for not having required irrelevant documentation of administrative trivia in order. What were our lawmakers thinking? 

I guess the HIPAA blunder proves that when politicians, insurers and healthcare IT entrepreneurs get together in vendor clubs like CCHIT, the only government-approved eHR certification authority, they can mandate damn well any law that suits their needs. 

Allscripts CEO Glen Tullman, who is an influential friend of Barack Obama as well as a Trustee of CCHIT told Bloomberg.com reporter Alex Nussbaum in an interview almost a year ago that providers should make the financial commitment “to ensure that doctors have some skin in the game.” 

Glen Tullman is only one reason our nation’s healthcare IT industry stinks from the top down. 

D. Kellus Pruitt; DDS

Dateline: 8.10.09 

Thank you, Kelly Mclendon, for providing a rare venue to possibly clear up a few items of uncertainty about eHRs in dentistry. First of all, if a technological advancement such as eDRs does not pay for itself, even with government subsidies, who pays for it? That seems like a quick way to increase the costs of dental care – and for what? How do dental patients benefit from expensive HIT solutions when the telephone, fax machine and US Mail serve us fine? 

Digitalization of records offers no benefits to dental patients. Only stakeholders who would grab our patients’ money benefit from HIT. Everyone else loses. Trusting, naive dental patients lose the most. 

Electronic dental records are expensive hazards. If you can think of a lame reason for them, please let me hear it. You can bet I’ve crushed it before. I’ve been down this road with others many, many times. 

Within a week, the government will price computerization smooth out of dentistry. Over 90% of dentists have patient identities on their computers today. If HIPAA is enforced, with or without the Red Flags Rule, I predict that less than half of the nation’s dentists will be computerized a year from now. 

As for your argument that eHRs somehow provide up-to-date and otherwise superior medical histories for dental patients, think about this: If someone changes a paper medical history, it leaves a paper trail. If an insurance thief alters allergies on a digital record to suit his or her own needs, nobody in the emergency room can tell. Whoever said “Paper kills,” lied. It is a catchy PR pitch, though.


Your thoughts and comments on this ME-P are appreciated. Feel free to review our top-left column, and top-right sidebar materials, links, URLs and related websites, too. Then, subscribe to the ME-P. It is fast, free and secure.

Speaker: If you need a moderator or speaker for an upcoming event, Dr. David E. Marcinko; MBA – Publisher-in-Chief of the Medical Executive-Post – is available for seminar or speaking engagements. Contact: MarcinkoAdvisors@msn.com


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