Human Trafficking: The Hidden Epidemic

This article by Patty Mitchell appeared in the July 2019 edition of Attorney at Law Magazine.

The 13th amendment to the constitution abolished slavery in 1865, however Human Trafficking is an epidemic of modern-day slavery. Despite legislation against it, there are an estimated 40 million victims worldwide per the International Labor Organization. This is a hidden crime that occurs daily before our eyes and we may unknowingly become a party to it, making awareness the first step in curing the disease. Human Trafficking is so prevalent in our society today, that state governments have taken steps to educate healthcare workers as the people on the front lines, most able to identify and intervene for the victims. Florida made education in Human Trafficking mandatory for licensure renewal of healthcare providers starting in 2019.

Human trafficking is defined by the federal government as the transporting, soliciting, recruiting, harboring, providing or obtaining of another person for transport for the purposes of forced labor, domestic servitude or sexual exploitation, using force, fraud or coercion, key elements to the diagnosis of human trafficking. Frightening statistics are associated with this crime; per the Polaris Project, 1 in 6 runaway children become the victim of human trafficking, usually within the first 48 hours of leaving home. Florida has the third highest incidence of human trafficking in the United States, behind Washington, D.C, and Atlanta, as reported in the Orlando Sentinel. The CNN Freedom Project reported an average cost of $90.00 for a trafficked human, with high return on investment for perpetrators of the crime. Trafficking victims are a reusable product, unlike a single use item such as drugs. Human trafficking is big business, it ranks third in criminal industry behind the illegal drug trade, and arms dealing with an estimated profit of $32 billion per year reported by the United Nations Office on Drugs and Crime.

The most prevalent and reported forms of Human Trafficking are: sex slavery, forced labor and organ trafficking.

Sex trafficking is the utilization of victims for commercial sex acts utilizing force, fraud, or coercion, or if the person induced to perform the act has not yet attained 18 years of age. According to the U.S. Department of Justice, every two minutes a child is trafficked for sex in the United States.

Labor trafficking is the recruitment and usage of persons for involuntary servitude, debt bondage or slavery. Key venues for labor trafficking include domestic work, restaurant/food service industry, agriculture (migrant workers), small business/retail, landscaping, and begging and peddling rings. Labor trafficking in foreign countries produces some of our favorite products, with such prevalence that the U.S. Department of Labor produces an annual list of Goods Produced by Child or Forced Labor available at https://www.dol.gov/agencies/ilab. They estimate 152 million children are involved in child labor with 48% under the age of 12, worldwide.

Organ trafficking involves the sale and purchase of human organs and constitutes approximately 10 % of all transplanted organs including lungs, hearts and livers per Global Financial Integrity. The World Health Organization (WHO) estimates 10,000 kidneys are traded on the black market annually which amounts to more than one per hour. The law of supply and demand plays a big role in organ trading. The National Kidney Foundation reports the average wait time for a kidney in the United States is 3.6 years, with 13 people dying each day, while awaiting an organ. This has caused an increase in Transplant Tourism, which is performed in 91 countries around the world per WHO. The circumstances surrounding organ trafficking are disturbing, with people kidnapped or sold solely to harvest their organs. Sometimes it is the final indignity after a victim of sex trafficking or labor trafficking is no longer useful in that capacity.

Recent high-profile human trafficking cases have highlighted the extent of the problem, for example the Super Bowl is the biggest trafficking event in the United States annually. 169 arrests were made in Atlanta in 2019 in association with sexual trafficking at Super Bowl LIII per report in Newsweek. Robert Kraft, owner of the New England Patriots was charged with soliciting prostitution in February 2019, in connection with a sex trafficking sting in Florida. The Nexium scandal that came to light in March of 2018 involved the alleged leader of a sex trafficking ring Keith Raniere, his recruiter, popular actress Allison Mack, and the heiress to the Seagram’s Liquor fortune, Clare Bronfman.

Human Trafficking is a modern-day epidemic, with prevalence throughout our society and throughout the world. SOAR is the acronym for Stop, Observe, Ask (is this human trafficking?) Respond. Awareness is the first step to making a difference. If you suspect human trafficking call the Human Trafficking Hotline at 1-888-373-7888.

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A New Cyberthreat – Medical Device Hacking

This article by Patty Mitchell appeared in the May 2019 edition of Attorney at Law Magazine.

Medical technology has come a long way in recent years, with advent of devices meant to improve patient safety and facilitate provision of care by health workers. New types of intravenous pumps deliver fluids and medications with built in safety nets such as hard and soft dosing limits manageable by the hospital pharmacy remotely. New model pacemakers offer monitoring and settings adjustment remotely over the phone, providing increased convenience and flexibility for the patient. Modern insulin and pain pumps with remote programming capability allow changing of dosing parameters.

These are wonderful innovations, but as with most technology the advancements are happening faster than the safeguards for their use can be put into place. It is a growing concern that cybersecurity is insufficient for the susceptibility of these devices to cause harm if they were accessed by an individual with malintent.

New on the scene in recent years are specialists called white-hat ethical hackers who work to expose the vulnerability of medical devices and offer solutions to weaknesses found in the software. Billy Rios and Jonathan Butts are two of the louder voices of this brigade, issuing over 500 advisories to vendors regarding potential weaknesses in their product security. Most companies are cooperative and work toward improving the security of their products – happy for the advance notice and opportunity to avoid a possibly catastrophic problem.

WHAT COULD GO WRONG?

In 2009, researcher Kevin Fu, at the University of Massachusetts, showed the vulnerability of a cardiac defibrillator to hacking which can cause problems such as failure to sense a lethal rhythm and draining the battery making the device non-functional. Jay Radcliffe, an ethical hacker demonstrated ability to take control of an insulin pump and deliver a lethal dose. Billy Rios revealed the vulnerability of Hospira intravenous pumps to hacking and dose alteration done via a hospitals wireless network. The fear is high, valid and led to Vice President Dick Cheney disabling the remote feature on his pacemaker, as a safeguard.

There has been no evidence of direct patient harm related to device hacking to date, but most experts believe it is only a matter of time. Forbes magazine reported an outbreak of “Wanna- Cry” ransomware that affected 48 hospitals in the UK, and several unnamed facilities in the United States. The hackers then demand a ransom for the release of the files threatening to destroy them if their demands were not met. The devices targeted in the U.S. were Bayer Medrad smart injectors which deliver contrast media during imaging studies. The Wanna- Cry caused the injectors to become non-operational for about 24 hours, however, in the UK the ransomware caused complete shutdown of imaging departments.

A lack of industry standard is associated with cybersecurity for medical devices and the concern is that as hospitals update their equipment, they will still not reflect best practices for technology safety.

The FDA has been implementing plans and processes to address this new threat.

GOALS OF MEDICAL DEVICE SAFETY ACTION PLAN:

  • Establish a robust medical device patient safety net in the United States.
  • Explore regulatory options to streamline and modernize timely implementation of post-market mitigations.
  • Spur innovation towards safer medical devices.
  • Advance medical device cybersecurity.
  • Integrate the Center for Devices and Radiological Health’s premarket and post-market offices and activities to advance the use of a Total Product Life Cycle approach to device safety.

AN ARTICLE IN CYBER SECURITY VENTURES OFFERED THESE INTERESTING STATISTICS:

  • The United States represents about 40% of the global market for medical devices.
  • The average hospital room contains 15-20 medical devices.
  • Each medical device has an average of 6.2 vulnerabilities.
  • Medical devices used by hospitals have an average use of 20 years per device making them prime hacking targets.
  • In 2017, 465,000 pacemakers were recalled by the FDA due to security vulnerabilities with potential to put patient’s lives at risk.

PROTECT YOURSELF

Know the product. Investigate and make sure the manufacturer built the device with cybersecurity concerns addressed. Share information via Shared Analysis Organizations which encourages individuals and businesses to identify, detect, and understand vulnerabilities in medical devices. Keep your medical device software up to date; this makes it harder to hack.

Innovations in medical device technology are exciting and provide improvement in patient care and safety and management of medical devices. It is important moving forward to improve the merging of cybersecurity with device development to safeguard patients from the threat of device hacking.

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Telemedicine: The New Frontier In Healthcare?

This article by Patty Mitchell appeared in the March 2019 edition of Attorney at Law Magazine.

We live in a digital age and what we have always seen and done in healthcare is changing. Telemedicine is an evolving field here to stay. As technology grows, physicians, nurses, as well as attorneys and the legal system must grow with it and face the challenges associated with this relatively new field of practice. A 2015 research2guidance report stated 80% of physicians use smartphones or medical apps in their practices. An article in the Washington Post reported 15 million Americans annually are already receiving remote care. Kaiser Permanente one of the nation’s largest healthcare systems reported it provides more virtual visits annually than it does in person. Are you ready to meet the changing face of healthcare?

The AMA definition of telemedicine is “the practice of medicine using electronic communications and information technology between a licensed health care professional in one location and a patient in another location.” Modern day telemedicine was first reported in the 1950s with transmission of radiology images over the phone for interpretation by a specialist. Telehealth programs originated out of a necessity to meet the needs of underserved populations and have grown to include follow-up visits, remote management of chronic disease, remote post hospital care, preventive care support, school-based telehealth, and assisted living support. Advantages cited for use of telemedicine include improved patient access, cost savings, and more engaged patients with improved outcomes.

Forbes magazine reported that global telemedicine will be a $66 billion industry by the end of 2021.

With change, always comes challenges. Telemedicine regulations and laws vary from state to state and patient location decides the applicable patient care law. This can cause providers to go awry either accidentally or intentionally. Common issues found within telemedicine cases involve:

Licensure of Providers

Physicians are usually required to be licensed in the state in which they treat a patient. Some large telemedicine companies employ physicians all over the country and connect patients with a doctor already in that state. The Interstate Medical Licensure Compact has 24 state participants and allows for treatment of patients within those states by doctors with compact licensure. Some states require a telemedicine license to practice that discipline within the state.

Medical Malpractice Coverage

Providers need to confirm that their malpractice insurance covers telemedicine, and what limitations there are. Telemedicine visits have been associated with reduced liability, reported due to performance of low risk services, such as routine follow up visits and improved documentation requirements by providers. Standard of care for the provider is often the same for telemedicine visits, as for in person services.

Physician Patient Relationship

States prohibit telemedicine services prior to establishment of such a relationship with a face-to-face visit. Exception to this can be consultation by a physician in another state, for a patient under direct care of a physician in the patient’s home state.

Reimbursement

May vary widely depending on state and providers. Medicare covers live services via audiovisual communication, for patients at a qualified site (e.g. physician practice or hospital, in a rural setting), with an authorized provider of telemedicine services (e.g. physician or physician’s assistant), and the service must be approved by CMS. In January 2018, Remote Patient Monitoring was approved by Medicare for reimbursement (e.g. ECG, blood pressure or glucose monitoring), when reviewed by a qualified practitioner, and requiring at least 30 minutes.

Online Prescribing: Follows state guidelines with notable exceptions. Passage of the Haight Act in 2008 prohibits prescribing of controlled substances without an in-person exam. This can be altered by the setting in which the consultation occurred, for example in a hospital or clinic with an onsite prescriber ordering the medications.

Informed Consent

Some states require documentation of informed consent for telemedicine services, and this is supported by the American Telemedicine Association.

Fraud and Abuse

False claims, antikick-back statutes and self-referral laws. A recent example of high dollar fraud involved medical supply companies hiring physicians to prescribe devices such as back braces and diabetic supplies not needed by the patients. A second case involved a group of pharmaceutical companies which used a Telehealth company to provide insurance information and unnecessary prescriptions for pain creams and medications to the tune of $931 million.

Privacy and Confidentiality

Telemedicine has higher risk of HIPAA breach. There can be pitfalls related to encryption and use of non-compliant video protocols such as FaceTime and Skype.

Telemedicine is the wave of the future, with state and federal laws falling behind usage and technology. Familiarity with the telehealth system and the possible issues are essential to effectively evaluate telemedicine cases.

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Biomarkers: The Key To Diagnosis?

This article by Patty Mitchell appeared in the February 2019 edition of Attorney at Law Magazine.

Traumatic brain injury (TBI) occurs when a blow, or jolt to the head causes injury to the brain with mild TBI (mTBI) found in 75 percent of reported cases. Moderate or severe TBI are easier to diagnose, treat and monitor due to clear evidence of clinical symptoms and often quantifiable lesions on imaging studies.

Per the National Institute of Health, symptoms of mTBI may not occur until days or weeks after the initial injury, with an estimated half of all TBIs occurring secondary to motor vehicle collisions (MVC). Diagnosis has historically been based on clinical symptoms and CT scan, although brain damage can be present without evidence on imaging.

Symptoms associated with mTBI include neck pain, headache, ear ringing, dizziness, nausea, trouble with memory, concentration, and attention, personality changes, sensitivity to light and sound and fatigue. Mild TBI can cause long term cognitive impairment in 15 percent of those diagnosed, affecting the individual’s ability to return to work or perform daily activities.

Lack of quantifiable damages in the face of clinical symptoms can make these cases difficult to prove or refute in both the medical and legal arenas. Delayed recovery from mTBI affects approximately 2 percent (5.3 million) of the U.S. population. Patients with symptoms lasting longer than three months are defined as having post-concussion syndrome.

Criteria for diagnosis of mTBI cited by the International Brain Injury Association include normal brain imaging studies (CT), no loss of consciousness greater than 30 minutes, no reduced consciousness or post-traumatic amnesia greater than 24 hours, or no Glasgow Coma Score below 13. These are the patients diagnosed with “concussion” and discharged to home from the emergency department.

The underlying pathology of mTBI is often at the cellular level, related to local pathophysiological changes, disruption of the blood brain barrier, alteration of cerebral blood flow, axonal and neuronal cell body injury and neuroinflammatory responses, undetectable with routine diagnostics.

This has prompted researchers to look for definitive testing to show damage related to mild TBI, to help guide treatment and to differentiate those patients with subjective complaints versus those with objective evidence of injury. Screening patients with the biomarker S100B has been performed in 16 European countries since 2000 to aid in diagnosis and treatment of TBI.

On Feb. 14, 2018, the FDA approved a blood test called the Banyan Brain Trauma Indicator (BBTI) which monitors levels of two biomarkers UCH-L1 and GFAP found to be superior to S100B and both released within one hour after TBI. Biomarkers are substances generated by cellular injury. The brain has a protective epithelial layer called the blood brain barrier which blocks water soluble molecules over a certain size from entering the brain. This barrier is damaged during TBI, making it more permeable and allowing these biomarkers to enter the blood stream.

Measurement of UCH-L1 and GFAP levels can be checked within 12 hours of the injury and have shown a 97.5 percent accuracy in detecting the presence of brain lesions and is 99.6 percent positive for those without lesions. The test was designed to alleviate unnecessary CT scans, the standard screening method, along with physical assessment for TBI. The test is not approved to confirm diagnosis of mTBI, although some have dubbed it the concussion test.

It is important to note that negative test results do not rule out something called a subconcussion, or mTBI without signs. Research related to BBTI is showing promise in use of the test to monitor recovery from TBI, with elevated levels months post-injury associated with worse outcomes. Studies have shown efficacy as a tool for assessment of return to play in athletes where there is concern about secondary concussions and development of chronic traumatic encephalopathy. Biomarkers are being tested as guides to treatment response for TBI patients.

The Department of Defense calls TBI the signature wound of recent wars with over 375,000 cases documented since 2000. It is hoped that the BBTI will “fill a critical need to quickly evaluate Troops in remote locations where there is a ‘knowledge gap’ in assessing how severe the injury is.” Early treatment of those diagnosed with mTBI has been associated with better outcomes. Manufacturer Banyan Biomarker has stated they are working on shortening the result time from the current three to four hours to less than an hour, making testing even more attractive in cases of suspected TBI.

The approval of the BBTI test by the FDA is a step toward more definitive diagnosis of mTBI. While BBTI is not a stand-alone prognosticator, when used in conjunction with clinical signs and symptoms, and some of the newer advanced imaging studies (Spect scan, DTI, fMRI) it can assist in identifying patients with mild TBI.

 

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Interview with Patricia MitchellRN, BSN, CLNC: From the Hospital to the Legal Arena

Attorney at Law Magazine First Coast publisher Thomas Brady sat down with columnist Patricia Mitchell, RN, BSN, CLNC to discuss her life and career.

Click here to read the full story at Attorney at Law Magazine.

AALM: Tell us what first drew you to your industry.
Mitchell: I had been working in the hospital setting for many years and was looking for a way to use all that knowledge in a new and exciting way. I learned about the field of legal nurse consulting, and thought that this would be the perfect marriage of nursing and medical legal litigation, and an new way to help people. Legal nursing is an extension of critiquing care; something done as a nurse on a daily basis. It is gratifying to help clients figure out the complexities in a case, explain the medicine and for the patients explain what happened, sometimes give closure.

AALM: What compelled you to start your own company?
Mitchell: I started Central Florida Legal Nurse Consultants because I wanted to be the Captain of the Ship so to speak. I wanted to have all the business interactions, products and services to have a personal touch I would be proud of, and the challenge of entrepreneurship was an added bonus.

AALM: How is your company different from its competitors?
Mitchell: Legal Nursing is a direct service to the client, so the culture of the company is very important and reflects whoever is at the helm. We treat our clients as we would want to be treated, just as in the hospital we treated our patients as if they were our family. Its not only a business, but an investment in the relationship, and is founded on trust.

AALM: How would you describe the culture at your company? The team?
Mitchell: We are passionate about our purpose, producing great work and helping people. The passion is the key, if you truly love what you do, the difference is apparent, then it becomes much more than a job.

AALM: Tell us about one of the most important lessons you learned from a personal or professional mentor.
Mitchell: Communication is key. This is the thing I find is the most lacking in the world today, and the easiest and most important to fix.
How has your field evolved since you first entered it? What’s the biggest positive and negative change?

The advent of the electronic medical record has been a game changer for everyone who does medical case review. It is critical to know how to navigate the records, what should be where, what is missing. On the up side, the records are no longer handwritten for the most part, illegible or difficult to decipher, and there is little need to sift through voluminous paper charts. On the downside, the EMR can be daunting to some folks, and change comes slower, there are still paper people out there.

AALM: What do you think is the most pressing concern for attorneys when it comes to your field?
Mitchell: I think there are a few big concerns — the first is the need to understand the medicine in a case. Often times this involves an in depth review of the medical record that few have time or background to do effectively.

The second would be finding someone to help whom they can trust and communicate with.

Location of experts can be a problems, particularly for plaintiff attorneys; finding the right expert for the case can be difficult, and more so if the case is regarding an unusual issue.

AALM: What changes do you see on the horizon for your field? How are you and your company preparing to stay ahead of the curve?
Mitchell: The medical field is constantly evolving with new standards of care, treatments, medications etc. This, of course, had upsides and downsides. It is critical to stay abreast of current trends in medicine through ongoing education, to continue the in depth analysis needed as a legal nurse consultant

AALM: What do you most enjoy about working with lawyers?
Mitchell: Lawyers in general are smart, curious people, necessary given the profession. The best ones know what they don’t know and are pro-active to seek answers, ask questions and quick to learn.

AALM: What is one of the biggest challenges you face in your industry? How do you overcome it?
Mitchell: Lack of knowledge about legal nurse consultants, what our role is, the services we provide and the benefits of using a legal nurse. There are still many attorney’s that don’t understand what we do, or how to best utilize our services. Education is the key; articles such as the ones published in Attorney at Law Magazine, explaining what an legal nurse consultant is, and does is valuable. We attend conferences to meet with attorney’s face to face, answer questions and teach about ways we can make the medical end of a case easier to navigate.

AALM: How are you involved in your industry as a whole? In the community?
Mitchell: We are very involved in our professional community, attending one or two conferences annually to network with other practitioners, and stay up to date on trends. We are active in the national organization , the American Association of Legal Nurse consultants (AALNC), and the National Alliance of Legal Nurse Consultants (NALNC). Patty Mitchell, founder , will be President of the local Greater Orlando Chapter of the AALNC for 2019, providing education, networking and resources to the legal nurse community in Central Florida.

AALM: Tell us about your ambitions for your career.
Mitchell: Working as a legal nurse and running Central Florida Legal Nurse Consultants is literally a dream come true. I plan to continue to grow the company and enjoy my clients and my work, as it evolves.

Republished from Attorney at Law Magazine with permission.

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