What is the HIPAA Privacy Rule? A health law scholar explains

What is the HIPAA Privacy Rule? A health law scholar explains

The Health Insurance Portability and Accountability Act’s Privacy Rule  is a federal law prohibiting health care providers, businesses and the people working with them – including administrative staff, laboratories, pharmacies, health insurers and so on – from disclosing your health information without your permission.

When people talk about HIPAA, they typically refer to the Privacy Rule provision established in 2003, which is just one part of a broader law initially passed by Congress in 1996. The Privacy Rule came into force after tennis star Arthur Ashe’s HIV status was publicly revealed and country music star Tammy Wynette’s health records were sold to tabloids. People were starting to worry about genetic privacy. And Congress recognized that the internet would make it easier for health care privacy breaches to occur.

Originally published in The Conversation - USE THIS LOGO

Why the HIPAA Privacy Rule matters

The HIPAA Privacy Rule gives you the right to control your health information disclosures so you can tell your health care provider what to share. If you don’t want to share some of your health information with your family members, you can tell your health care provider to withhold that information from them.

However, HIPAA only protects health care information held by specific kinds of health care providers. For example, health care data on your Apple Watch or Fitbit is not usually covered by HIPAA. Genetic data you enter on websites like Ancestry.com is also not covered by HIPAA. Other laws or agreements like the privacy disclosures required on many apps may protect that information, but HIPAA does not.

Sometimes people try to use HIPAA as an excuse for actions it doesn’t actually cover. For instance, some people who refused to comply with coronavirus-related mask rules in stores asserted that they couldn’t be asked to explain why because of HIPAA protections. But that’s not how this privacy law works: It’s legal for someone to ask you about your vaccination status. And anyone can provide information about their own vaccination status (or any personal health information) without violating HIPAA.

Are there exceptions to the HIPAA Privacy Rule?

Certain exceptions to HIPAA’s nondisclosure requirements allow covered health care providers to disclose patient information to help treat another person, protect public health and aid in certain law enforcement investigations.

During a pandemic, for instance, public health departments can provide information about how many people have tested positive for a disease, but they cannot mention specific names to the general public unless it’s necessary to alert particular people that they may have been exposed. This is because HIPAA and other privacy laws require them not to release any more information than is needed to keep people safe.

Helping Patients Understand Mental Health Treatment Options

Helping Patients Understand Mental Health Treatment Options

Treating a patient with a mental health issue is unique within the medical field. They are often dealing with paranoia, anxiety, social withdrawal, depression, or a combination of these symptoms and others.

In addition, society has generally been slow to acknowledge and accept mental illness. There is a still a feeling that a patient may be “faking it” or just needs to “get over it,” so it’s important that we help our patients understand their mental health treatment options.

Right now, there is no genetic test that can determine if a patient has a mental illness or if he or she is likely to develop one, as exists with breast cancer.

However, there are advancements in the field that the public is starting to embrace. Most Americans (67%) say they would be willing to take a genetic test to determine the best treatment plan for mental illness if they received that recommendation from a clinician. That’s an increase of 4% for that question over last year, according to the 2017 Genomind Mental Health Poll .

While the people polled were more open to taking a genetic test if diagnosed with cancer (76%), heart disease (75%), or diabetes (72%), the disparity between the acceptance of genetic testing for mental health treatment and for the treatment of those other chronic illnesses is shrinking.

As a psychiatric and addictions advanced practice nurse, I think there are reasons for this change. First, more Americans in the poll said they knew an immediate family member, relative, or friend diagnosed with mental illness (31% stated this, which is up 3% in the past year). There were large increases the answer to this question among Hispanics (a 9% increase) and those in the South (an 8% increase), compared to the 2016 results. When we know someone dealing with a mental health struggle, I think we are more willing to understand and accept expanded mental health treatment options.

I believe there is also an increased understanding that prior to genetic testing, all we had with pharmacotherapy as clinicians was an often lengthy trial-and-error process based on the symptoms presented, the clinician’s education and experience, and the drug’s indications.

Monitoring for Polypharmacy

Clinicians and patients are also increasingly concerned about polypharmacy, the concurrent taking of multiple medications, which is especially prevalent in the elderly. The use of genetic test results to better understand polypharmacy could be another way to build support for such testing.

For example, I treated a 74-year-old woman who initially presented with 26 different medications (over-the-counter, supplemental, and prescription) that she was taking on a daily basis.

Because the patient’s symptoms were not well controlled, the information offered through the genetic test results and an online drug interaction tool were especially helpful in suggesting which drugs may have been contributing to adverse effects, which drugs may have been less effective based on her genetic variants, and which drug–drug interactions may lead to potentially harmful events. The tool that I use, the Genomind Drug Interaction Guide (G-DIG), also allows clinicians to assess how smoking or drinking coffee can affect the patient’s specific drug metabolism.

Utilizing the results from the patient’s genetic test and the information from G-DIG, I was able to explain to the patient the drug–drug interactions that might be interfering with her overall well-being.

Additionally, I was able to determine which of the various drugs she was currently taking would likely not have the intended effect or, worse, lead to some of the side effects she was experiencing based on her unique genetic variants. The patient and her family were eager to begin chipping away at the medications which testing had indicated had a potential lack of efficacy or an increased risk of adverse events.

As the patient’s medication profile was extensive, we began slowly, so her medical condition would not become destabilized. Over a period of a few months, we were able to eliminate 10 drugs from her regimen. The patient began to experience greater energy, less pain, increased motivation, and overall a better self-reported quality of life.

An important point to emphasize is that the genetic test is neither directive nor diagnostic. For those prescribing advanced practice nurses and other clinicians who may feel challenged by interpreting the results of genetic testing, I can assure you it is well within your ability to do so and that the companies that offer the testing have extensive clinical support teams to guide you through the results and the pharmacological decision-making process if the need arises. I will also point out that genetic testing to personalize medication decisions is not a new science: Oncology clinicians have been utilizing such reports for years to personalize chemotherapy regimens for their patients.

With the ability to test for drug metabolism, drug–drug interactions, and the possibility of how or if a drug will work for a patient, more individuals are now willing to explore genetic testing to clarify and personalize mental health treatment for psychiatric disorders. In my experience, the ultimate result has been healthier and happier patients.

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The Value of Genetic Testing to Psychiatric Nursing

The Value of Genetic Testing to Psychiatric Nursing

When I tell people I’m a psychiatric and addictions advanced practice nurse, they are a bit surprised after I share with them my family origins. You see, I come from multiple generations of pharmacists, dating back to the turn of the 20th century when my great grandfather patented medicines around the world and maintained company with the founding fathers of Eli Lilly and Johnson & Johnson. My grandfathers, on both sides of my family, my parents, and numerous aunts and uncles also studied and practiced pharmacy.

Nevertheless, I ultimately decided my career path would include a deep understanding and respect for the role of the pharmacist, but I wanted to practice nursing and provide care to patients with psychiatric and substance use disorders. As an advanced practice nurse, I was able to incorporate prescribing into my practice as a master clinician in psychopharmacology.

My extensive connection to pharmacy and pharmaceutical agents, and psychotropic medications in particular, is why I have embraced pharmacogenetic testing for patients who present with complex diagnostic issues and for whom various trials of medications have failed to provide symptom relief and emotional stability.

Genomind’s Genecept Assay is a simple, in-office, cheek swab-based test that I offer to patients to assist with personalizing their psychopharmacological regimen; it’s painless and easy to perform. The assay explores key pharmacokinetic and pharmacodynamic genes, which affect how the patient’s body may metabolize medications and the potential impact the medication may have on the body. This information provides an understanding of whether a drug is likely to either work properly or produce adverse effects for a patient before he or she even tries it. The details provided by the assay also offer insights into the dosing of medications and potential drug-to-drug interactions based on their metabolism by the various CYP450 system enzymes located in the liver.

With this information, along with the patient’s symptom presentation; medical, psychiatric, and substance use histories; family history; and medication (including over-the-counter and supplemental medications) history, I am able to narrow down the pharmacological treatment options so patients can feel better, faster.

In 93% of patient cases , the Genecept Assay influenced clinicians’ decisions about medications. It helps reduce the trial-and-error approach, time, expense and struggle of finding the right treatment options. I think the results of the assay are especially helpful for patients who are frustrated after multiple medication failures when trying to find a medicine to alleviate their symptoms. As a clinician, the more information I have in my toolbox when working with a patient, the better.

An example of the beneficial results received as a result of using genetic testing occurred when I treated a woman who was in her early 60s and who said she had suffered from a lifetime of depression, dating back to her early childhood. The genetic testing helped me realize she was suffering from low dopamine levels, our pleasure enhancing and energizing neurochemical located in the prefrontal cortex of the brain, the area responsible for executive functioning, including motivation, attention, concentration and organization. This was an ah-ha moment for both my patient and me, as it explained why so many past trials of medications were either ineffective or contributed to adverse side effects.

Based on the results of the Genecept Assay and my patient’s history, I prescribed a psychostimulant, typically reserved for the treatment of Attention Deficit Hyperactivity Disorder. Once dosed to the appropriate level with guidance from the pharmacokinetic results of the assay, it revolutionized her life; the depression lifted and her quality of life improved dramatically for the first time she could recall. Now, at the age of 70, she remains free of depression and is catching up on the life that depression stole from her for so many years.

An important point to emphasize is that the test is neither directive nor diagnostic. For those prescribing advanced practice nurses and other clinicians who may feel challenged by interpreting the results of genetic testing, I can assure you it’s well within your ability to do so and that the companies who offer the testing have extensive clinical support teams to guide you through the results and pharmacological decision-making process. I will also point out that genetic testing to personalize medication decisions is not a new science, as oncology clinicians have been utilizing such reports for years to personalize chemotherapy regimens for their patients.

As health care and the disciplines of psychiatry and addictions continue to evolve, personalized medicine will become more and more the norm. Advanced practice nurses have an opportunity to serve in a critical and leading role during this emerging period by adding pharmacogenetic testing to assist in streamlining psychotropic medication options for their patients. Genetic testing is one of the keys to unlock the mysteries of prescribing psychotropic medications and should be added to the clinician’s arsenal of clinical tools in order to to maximize improvement in symptom relief and quality of life for our patients.