Future of Healthcare | Technology

Will Your Copier or Medical Equipment Become a Whistleblower?

Dr. Bob, the group’s compliance officer, has HIPAA on his mind almost all the time, that is, when he’s not thinking about coding or Stark or the federal Anti-Kickback Statute.

So he made sure that his notebook computer’s disk drive was encrypted. And, at the end of the computer’s useful life, he took care to permanently erase the drive. He then arranged for a vendor to come onsite to remove and physicially destroy the disk.

The point, of course, was to eliminate the possiblity that any Protected Health Information (“PHI”) could be improperly disclosed.

After all, Dr. Bob was familiar with the errors made by other “Covered Entities” under HIPAA, such as the VA, that tossed out computers willy nilly, exposing patients’ individually identifiable health information.

Dr. Bob decided to call it a day. As he walked out of the office, he noticed the new copier that had been delivered earlier that day. Great, he thought; the old one jammed almost every time he used it.

At midnight, Dr. Bob bolted up from his slumber. “What the &*&$^ happened to the old copier?????”

When most physicians and healthcare administrators think about electronic PHI, the default focus is on computers. After all, computers store information and that information might constitute PHI.

But PHI lurks in the strangest places in a physician’s office, in billing and collection departments (both in-house and outsourced), and in healthcare facilities of all sorts. Like on the copier that just caused Bob to wonder whether there’s been a major PHI breach.

Modern office machines, from copiers to printers to maybe even label makers have memory devices, and those devices may be chock full of PHI.

In similar manner, electronic medical equipment used for diagnosis or treatment can also possess memory that stores PHI, especially as those devices have been made “smarter” in order to communicate with electronic health record systems.

The memory in those devices must be considered and treated in the very same manner as the memory in computers. It must be protected and it must be destroyed when no longer in use, not just hauled away by a vendor or a manufacturer (who may or may not have been treated as a HIPAA Business Associate by the practice or facility – big mistake!) or tossed into the city dump or even the city recycling program.

If not, it can find its way into the wrong hands and land you in a world of trouble, both in terms of HIPAA and related HITECH Act requirements and in terms of what that information may reveal in respect of your other compliance issues.

People are afraid of being replaced by machines in the future, but they don’t spend much time thinking that their just-replaced multi-function printer/scanner/copier may be ratting them out today.

Comment or contact me if you’d like to discuss this post.

Mark F. Weiss


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Changing Market | Technology

Dr. Robot Will Cut You Now

Back in the dark ages of medicine, I mean, in 2014, I wrote about competition from Dr. Nurses and Assistant Physicians. Now I’m writing about Dr. Robot. Same issue. Just on steroids.

An article by Michelle Starr published last week on Cnet.com reported that a team of scientists at Children’s National Medical Center has created a robot capable of performing soft tissue surgery. It “sees” in three dimensions both in the visible spectrum and via near-infrared night-vision. Through the use of florescent markers, it can see and follow the movement of soft tissue.

In a test run suturing together two pieces of pig intestine in vivo, the robot, named STAR (Soft Tissue Autonomous Robot), beat out experienced surgeons, laparoscopy, and “old fashioned” robot-assisted surgery via the Da Vinci system.

It doesn’t take much to see where this is headed. One of the scientists involved in developing STAR, was quoted as saying that within the next few years, STAR “will inform and work with surgeons in supporting better outcome. (sic)”

My question is why he doesn’t realize that once perfected, STAR might not need a surgeon at all. Perhaps it will need a Dr. Nurse or a Physician Assistant, or a nerd who received his or her training at the Game Stop at the local mall.

I don’t have a crystal ball, but I’m not blind, either.

At the same time that cases are exploding out of hospitals to the outpatient setting, a move that is fueled by many factors including technology, technology is also fast enabling a mechanization of medicine just as it enabled a mechanization of industry. The robots building F-150s (or, if it makes you feel better, Teslas) don’t go on strike, take breaks, or call in sick.

The maturation of medical mechanization signals a changing role for physicians. One thing’s for certain: The more control (i.e., ownership) you have over the outpatient facilities that employ emerging technology, the more control you will have over your place in this future.

Comment or contact me if you’d like to discuss this post.

Mark F. Weiss


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Future of Healthcare | Technology | The Business of Healthcare

Profiting From 3-D Printed Pills

If the future of surgery is medicine, then the future of medicines is compounding, the individualization of dosages and drug combinations.

Earlier this month, the FDA approved the first 3-D printed drug product, Spritam, developed by Aprecia Pharmaceuticals.

The layering process of 3-D printing allows Apecia to tightly package active ingredients in precise dosages.

A far more complex use of that technology is certainly not far behind. One that will open the door to mechanized compounding of drugs at patient-by-patient, individualized dosages: a customized 3-D printed pill for Mr. Smith and a different one for Ms. Jones.

For compounding pharmacists, the expansion of the use of 3-D printing technology will mean even more demand, whether on a small scale of production (i.e., a local pharmacy) or on a large one (e.g., a centralized facility filling hundreds of thousands or millions of prescriptions for individualized medications).

At the small scale end of this continuum, the move from large scale drug manufacturing to individualized drug compounding via 3-D printing is the equivalent of the morphing of the million dollar printing press into the laser printer or ink jet in your home office. It’s the dematerialization and democratization of drug manufacturing.

For physicians in states that either allow them to own interests in pharmacies or to dispense pharmaceuticals from their practices, the technology opens new doors to patient care and to profit.

Underlying all of this, for physicians and pharmacists alike, is the opportunity to do new types of deals with unique structures. That requires a new way of thinking. It also requires careful compliance with a host of regulatory issues, from the federal Anti-Kickback Statute to Stark to the Federal Food, Drug, and Cosmetic Act.

But those are just the problems on the route to outcomes that will be profitable for patients and profitable for providers.

Comment or contact me if you’d like to discuss this post.

Mark F. Weiss


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