HIPAA & Health Information
The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A). In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.
Protected Health Information is seeing a surge of breaches on the cyber security front due to contractor error. It’s also impacting the most consumers in comparison to other data breaches and, in some cases, has the power to cause chaos in national infrastructure. Advances in technology and compliance measures can stem the tide and protect the most valuable information in consumers lives.
In a time when data breaches occur fairly frequently, whether it’s credit card information being stolen from department stores or a credit reporting bureau breach affecting hundreds of millions of customers, keeping personal information private seems to get harder every day. That fact may give patients pause when they are asked to sign up for an electronic health record account. A 2017 survey listed electronic health record management as one of patients top concerns. Changes in recent years have led to changes in compliance measures that make electronic health records security an added benefit to patients and ensure the continued increase of their adoption.
The EU General Data Protection Regulation (“GDPR”) is now in effect as of May 25, 2018, and has been a prominent topic of international debate across multiple sectors as companies look to adjust to new stringent regulations in data management. With a wide scope (the GDPR now applies to all organizations possessing personal data of individuals based in the EU) and steep penalties for companies that fail to comply, companies across the globe are spending millions of dollars in preparation.
An increasing number of companies are providing fitness trackers for their employees as a part of their benefits package. The use of fitness trackers has been steadily growing over the past few years, and is predicted to hit a shipment size of 240.1 million devices by 2021. Even though the popularity of these fitness trackers has boomed, their compliancy with HIPAA has not kept up with them as quickly. A few companies that make fitness trackers have become HIPAA compliant, such as Fitbit and Apple. However, some companies have remained silent as to whether they are or plan on becoming compliant. While fitness trackers have been shown to have an overall positive effect in corporate wellness programs, corporations should remain up to date with how to keep their employees’ health information secure as well as ensure that the fitness tracker that they are providing is HIPAA compliant.
The Trump administration has established a new division within the Department of Health and Human Services (HHS) called the Conscience and Religious Freedom Division. The stated purpose of this office is to “restore federal enforcement of our nation’s laws that protect the fundamental and unalienable rights of conscience and religious freedom.”
One day after the creation of this division, HHS proposed a new rule, providing further protections to healthcare workers who object to providing certain types of care to patients—including elective sterilization, gender reassignment surgery, or emergency contraception—based on their personal religious beliefs. Additionally, the Trump administration issued a new directive, reversing an Obama administration directive which prohibited states from refusing to send federal funds to qualified providers. This new division, new rule, and new directive serve to ensure the already-existing rights of physicians, nurses, and healthcare staff at the expense of their patients.
It happens in every emergency department: a law enforcement officer comes into the ER at two o’clock in the morning and demands to test the blood alcohol levels of a patient brought in after an auto accident. The officer pulls an exhausted nurse to the side in the hopes that the nurse will forget his or her training, or become anxious enough to give up the information for fear of being arrested. Yet no matter the specific facts, the question remains: can a hospital give law enforcement officers a patient’s PHI without authorization from the patient? In some situations, is it even required?
There is a provision under the HIPAA Privacy Rule that allows, and in some cases, requires, entities to disclose patient’s PHI to law enforcement without the patient’s authorization. However, state law can complicate this picture with more restrictive regulations and guidance.
On September 25th, a former Okaloosa County, Florida paramedic, Christopher Wimmer, was sentenced to six months jail time and three years’ probation for taking “selfies” with incapacitated victims in ambulances last year and sending them to a co-worker. He and his co-worker, Kaylee Renee Dubois, were engaged in a “selfie war” with each other and snapped images and videos of patients in ambulances who were unconscious, sedated, intoxicated, or incapacitated. In total, 101 photos, 64 videos, and 41 patients were photographed or recorded during the so-called war, and a mere three patients consented to photographs being taken of them. Employees’ missteps with the privacy rights of patients have a negative lasting effect on their employer, their own career, and their patients.
Though the rain has stopped falling, Houston is still dealing with the aftermath of Hurricane Harvey, one of the largest and most destructive rainfall events on record. Healthcare providers in particular find themselves struggling to keep up with the various health problems caused by the flooding itself, on top of getting life-sustaining care to individuals with chronic or preexisting conditions. Crises like Harvey create serious problems for the delivery of care, but also for regulating it—circumstances are so uniquely devastating that standards can feel like barriers to necessary medical attention. And when family and friends are desperate to know if their loved one is out of danger, even the right of privacy seems negligible.
However, natural disasters and emergency events shouldn’t be used as an excuse to regulate away protections individuals depend on, such as the privacy and confidentiality of their personal information. Regulators must be careful when determining how to respond in a crisis—overreaching for the sake of bringing relief or under-regulating for flexibility can leave the public high and dry when the floodwaters recede.
In an unprecedented act, the Office for Civil Rights (OCR) entered into a settlement agreement with Presence Health Network based on the healthcare system’s failure to timely report a breach of unsecured protected health information (PHI). Under the Breach Notification Rule of the Health Insurance Portability and Accountability Act (HIPAA) a covered entity must notify affected individuals, the Department of Health and Human Services (HHS), and the media for breaches affecting 500 people or more. Presence Health will pay $475,000 and implement a corrective action plan (CAP) to address misunderstandings in workforce member roles and responsibilities relating to the notification process.