Medical Spa Lawyer
Paddy Deighan, the Premier Medical Spa Lawyer

 Last month, a medical team from the University of Pennsylvania did something rather astonishing.

The medical team attached the veins of an alive, but brain dead patient to the veins to a  large machine with pig liver mounted in the middle of it. 

For three days, the man’s blood passed into the machine, through the pig liver, and back into his body.

This “extracorporeal,” or outside-the-body, liver—whose initial test is designed to help people survive acute liver failure, which can be caused by infection, poisoning, or (most commonly) too much alcohol.

A damaged liver can’t do its job removing toxins from the body, processing nutrients, and making protein. Hooking people up to an external one could buy them time.

The liver test in Philadelphia is also the latest effort to experiment with organs from pigs that have been genetically engineered so their tissues are more compatible with people.

To do that, they have all made genetic changes to pigs so that the animal tissue is cloaked from the human immune system, which would otherwise attack the organs.

But using a liver outside the body largely avoids the issue of longer-term organ rejection because it only needs to work for a few days, not years. And the gene edits made to the pigs do seem to protect the organs from severe rejection in the short term. “Here there is no complex immunology,” says Shaked. “We eliminate the rejection question because we don’t use the organ for long. It’s more like a piece of machinery.”

The idea is to use the external organ to support people with liver failure until a human liver transplant becomes available for them or until their livers bounce back, something that’s possible given the organ’s impressive ability to regenerate.

Patients who could benefit include those who overdose on painkillers or who drink too much alcohol over time and develop acute liver failure.

At the height of the arms race, the United States and Russia recognized that the doctrine of “Mutually Assured Destruction (MAD) was detrimental to both nations. MAD was such that in any conflagration, both countries as well as the rest of the world would likely be destroyed. Accordingly, it was unlikely that either country would initiate a nuclear war.

Representatives of both countries met and it was decided that the issue of which nation would control nuclear arsenals and govern the world would be decided by a dog fight. The losing nation would have to lay down its arms. Each nation had five years to breed the best canine fighting machine.

Russia went right to work…they gathered the best specimens of Dobermans and Rottweilers. They bred them with Siberian wolves. They careful selected puppies from the best breeders. The hired the top trainers. They taught the animals to be as mean as possible. They decided to cheat and gave the animals steroids. These dogs were so mean that their cages had three inch metal bars.

After five years, it was time for the fight. The Russians were abundantly confidant. No one could do more than they did to assure victory.

The American team appeared with a none foot long Dachsund. The Russians laughed for minutes. They were assured victory. A Dachsund. It appeared that the Russians actually had sympathy for the American team. It was that laughable.

The moment arrived. the cages were opened and the Dachsund wrapped itself around the Russian beast. The Russian beast made the first move to bite the American offering in the neck. However, the American animal opened its mouth and swallowed the Russian animal in one bite.

To say that the Russians were astonished is an understatement. They were flummoxed. They approached the American delegation and mentioned all that they did to assure victory. The Americans replied, “that was nothing, it took our best PLastic Surgeons five years to be able to make an alligator look like a Dachsund”. LOL

Good or bad…I just report the news!! The Biden administration rescinded the Trump policy that provided health care workers relief from a perceived burden of being required to perform termination of life procedures on patients when doing so conflicted with their religious or moral beliefs. The Trump policy was effective in 2019 and was recently rescinded on part by the Biden administration.

The Trump policy would have stripped funding from health care entities that required workers to perform procedures that conflicted with their religious or moral beliefs. Such procedures were not limited to termination of life. They also included such other issues such as contraceptives, gender affirmation procedures and sterilization.

I just had a conversation today with an IT person person from a health care provider client. he raised some valid points about a particular situation. It reminds me that HIPAA is one of the most prevalent healthcare laws as well as one of the most misunderstood. Despite years of experience, the IT person today had what I believe to be misguided notions of “protected health information (PHI)” and what is actually protected under HIPAA.

In order to determine whether something is violative of HIPAA, we need to first understand whether the situation applies TO HIPAA (or whether HIPAA applies to the situation). Frequently, the answer to this is no, so there is no reason to analyze HIPAA issues.

It is interesting that as of now in early January 2024, I read that HIPAA violations are increasing and HIPAA compliance is also increasing. This may seem contradictory. However, technology is advancing rapidly and this contributes to the apparent discrepancy. It is important to note that HIPAA has many aspects: some pertain to patients and their rights and some pertain to healthcare facilities and their obligations. It is the goal of everyone to protect PHI.

So what is reality and what is fiction? The reality is that technology as applied to healthcare is booming. artificial intelligence (AI) is fueling patient care, diagnostics and treatment. It is also creating scenarios for HIPAA violation. I frequently state that technology is always ahead of the law. the law adapts to change (technology). However, the further reality is that healthcare facilities are held to a high standard of care when trying to protect PHI.

Accordingly, healthcare facilities must constantly monitor their flow of patient information. This includes Revenue Cycle Management (RCM), Electronic health records and electronic medical records as well as staff methods of communicating with patients and other facilities. Unfortunately, there is no standard for large facilities and a simpler one for smaller facilities.

HIPAA is a moving target. Most scenarios are viewed on a case by case basis. This is the way the law in the United States is designed. It may or may not be the best system (I believe that it is because it is ore flexible). However, this makes it difficult to know whether you are in compliance.

One thing that is certain, HIPAA changes. Constantly. There are new changes for 2024. Some entities purchase software that is “HIPAA compliant”. This is not enough!

Now to the fiction. Entities and software vendors routinely advise me that they are “HIPAA compliant”. I really do no think that anyone can claim this because HIPAA is a moving target and it changes regularly. In any event, it may be troublesome to state this (perhaps equally troublesome to forego sayings it)!

The bottom line is that HIPAA should be addressed at least twice per year. If you are not equipped to do so, please bring in someone to review your operations to render an opinion. Sometimes just having an expert opinion goes a long way if you are in a compliance scenario!

Prior to the the end of the year, I wrote that utilization of telemedicine was down in 2023. This may be a surprise to many. Of course telemedicine was reinvigorated during the pandemic when patients and providers utilized it as a preferred method of care. Perhaps it was only natural that there would be a drop off in the post pandemic delivery of care.

However, 2024 and beyond should see an increase in telemedicine (telehealth). The fundamental reasons for use of telemedicine are still sound. For providers and health systems it is more efficient and efficacious, For patients, it is more convenient. Patients can initiate treatment from many devices and from many locations and they may do so 24/7. So it sounds to reason that utilization will rise.

Providers love the efficiency. Patient data is gathered more efficiently and care may be delivered in fewer visits due to the efficiency. Patient flow is no longer an issue and patient care can be delivered when providers have time.

Another important aspect of telemedicine is that as we integrate new technology, telemedicine, which is also known as asynchronous care, makes it easier to interface between the new technology and the patient health records. This alone is reason enough to embrace telemedicine.

The U.S. Department of Health and Human Services’ Office of the National Coordinator (ONC) recently provided guidance into the utilization of Artificial Intelligence (AI) in the health industry. Of course it is government agency so the guidance is in a nearly 1,000 page document. The is the first comprehensive U.S. regulation delineating the responsible use and oversight of AI used in connection with health care related matters.  

Artificial Intelligence in healthcare is a contentious topic. Many believe that since AI is in its infancy, and it should be allowed to develop naturally and as outcomes and experience expand, guidance/regulation can follow.

I am known to say, “the law always lags behind technology”. This is natural. However, others believe that the technology of AI is advancing so rapidly that the time to govern (act) is now. There probably is no right or wrong answers as long as the regulation is not too burdensome as to curb technological growth. Nonetheless the ONC states: “we believe now is an opportune time to help optimize the use and improve the quality” of these AI tools.

Beginning next year – January 1, 2025, certain developers of healthcare ITs must meet new transparency requirements.  Those that create and use IT that supports decision-making based either on clinical evidence (this is known as evidence-based decision support) or on algorithms or models trained on data to make predictions, recommendations, evaluations, or analysis (aka Predictive Decision Support Intervention or DSI) will have to provide information about how the IT is designed and developed, the data sets used to train the IT (including, for example, data related to race, ethnicity, sexual orientation, and gender identity), and how the IT is continually evaluated.  Health IT developers of Predictive DSI must perform risk analysis and risk mitigation “related to validity, reliability, robustness, fairness, intelligibility, safety, security, and privacy.”

The close to 1,000 pages do, provide a detailed map of how AI tools can be developed and monitored responsibly.  Developers will be expected to understand and be able to explain how the technology was designed as well as how it works.  

Happy New Year!!!

A day does not pass without Ai being in our lives. We hear about it, we utilize it, we are affected by it. Healthcare is the largest industry in the United States. It is roughly 18% of our Gross Domestic Product (GDP). Naturally, it is a heavily regulated industry and it should be regulated since lives are at stake.

So it seems only natural that health care providers would be heavy adopters of AI. Are they? The answer may surprise you!

A recent survey indicated that 67% of primary care physicians had yet to adopt AI protocols. It seems that doctors rely more heavily upon Electronic Health Records (EHR) than AI. The main impediment to AI adoption in healthcare (according to the survey and logically) was a lack of trust in AI. This may stem from a lack of familiarity or feedback from colleagues. It is difficult to say.

However, one thing is clear. Adoption of AI in healthcare will be the future. Many diagnostic tools that rely upon AI are going to change the future..examples are Canary Speech and Nano Diagnostics.

HIPAA policy should be reviewed and updated consistently. Many (most) healthcare facilities and vendors overlook this essential function. Now is a good time to review HIPAA policy because there are changes coming in 2024.

HIPAA was first enacted waaaay back in 1996. Much has changed. A lot will change in 2024 – including fines!! Going up!! In 2005, the government drafted the Health Industry Cybersecurity Practices (HICP) guidelines to provide healthcare organizations with recommendations and best practices for complying with HIPAA and protecting their patients’ data. Throughout the HICP’s history, these guidelines were largely self administered by entities. Entities were given advice on how to maintain cyber security and HIPAA compliance. This is changing.

HICP guidelines have been dramatically revised. It is prudent to review the changes and respond accordingly. Cyber security and cyber threats have become so complicated that is has become burdensome for healthcare entities and vendors to stay ahead of the threats. without expert guidance.

The goals of HIPAA have remain unchanged…protect patient information. However, the cyber security threats have increased and healthcare entities must be diligent to remain ahead of the threats and this typically requires expert guidance.

Telemedicine has been a viable option in healthcare for about 30 years. However, it became part of mainstream medicine during the pandemic when patients were unable or unwilling to visit health care facilities. It seems strange that just a short time later, the utilization of telemedicine (telehealth) is dropping.

However, medical claims for telemedicine have DROPPED 5.4% since the pandemic ended.

The reason for this seems to be that patients just do not embrace telemedicine despite the convenience and (presumably) better access. Will this trend continue? One factor will be reimbursement to providers. Providers can promote or fail to promote based upon reimbursement and utilization of staff resources.

Naturally, some specialties such as dermatology are very visible and do not necessarily lend themselves to telemedicine, However, the benefits of telemedicine are hard to ignore so perhaps the future for it is bright!!

Happy New Year!!