HIPAA & Health Information
It cannot be denied that the COVID-19 pandemic has led to many novel legal and regulatory issues. One topic of major concern both domestically and abroad is how to manage the massive amounts of consumer data being collected in the attempt to quell the spread of the virus. This issue is especially complicated to address in the United States, where a convoluted patchwork of state and federal laws interact to create a relentlessly fragmented data regulation system. Now, as state and local governments, along with tech giants like Apple and Google, continue to roll out contact tracing applications, the need for comprehensive data privacy regulation is more pressing than ever.
The Health Insurance Portability and Accountability Act – enacted in 1996 by the U.S. Congress and signed by then-President Bill Clinton – has long served to maintain the standards of electronic health records and patient privacy, among many other provisions. Violating HIPAA can result in both criminal prosecution as well as steep civil penalties. As the healthcare industry transitioned from the use of paper records to storing patient data on electronic health records over the last two decades, health organizations have learned to adapt to HIPAA compliance, with many increasing their compliance programs by hiring full-time compliance officers, designating an individual as the compliance manager, and/or appointing a compliance committee within the organization.
On November 18th, 2019, Congress introduced the Stop Marketing and Revealing the Wearables and Trackers Consumer Health Data Act, known as the Smartwatch Data Act. The Smartwatch Data Act was introduced by Democratic Senator Jacky Rosen and Republican Senator Bill Cassidy, due to Google’s desire to acquire fitness tracker manufacturer Fitbit in 2020. Since notice of this acquisition, privacy advocates have raised concerns about how Google will use personal health data collected through Fitbit devices. Therefore, this legislation aims to ensure that health data collected through fitness trackers, smartwatches, and health apps, cannot be sold without consumer consent.
Earlier in 2019, a lawsuit was filed against University of Chicago Medicine, University of Chicago Medical Center, and Google. The suit claims that patient information was shared with google as part of a study aimed to advance the use of Artificial Intelligence, however, patient authorization was not obtained and the data used was not properly de-identified. In 2017, University of Chicago (UChicago) Medicine started sending patient data to Google as part of a project to look to see if historical health record data could be used to predict future medical events.
On September 9th, 2019, the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) issued its first enforcement action and settlement under its Right of Access Initiative. This came as a reaction to Bayfront Health St. Petersburg (Bayfront) paying $85,000 in fines to OCR. Bayfront adopted a corrective action plan to settle a potential violation of the right of access provision of the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule after they failed to provide a mother timely access to the records about her unborn child. In response, the OCR Director, Roger Severino, stated “[w]e aim to hold the health care industry accountable for ignoring peoples’ right to access their medical record and those of their kids.”
The Health Insurance Portability and Accountability Act (HIPAA) and the Patient Protection and Affordable Care Act (ACA) jointly create national standards for electronic transactions, code sets, and unique identifiers. The ACA introduced Administrative Simplification provisions in 2010 and now the Centers for Medicaid and Medicare Services (CMS) has launched a Compliance Review Program to ensure that HIPAA covered entities are abiding by the Administrative Simplification rules.
Despite all preventive measures that hospitals and health care systems put in place to stop data breaches from occurring, employees at these entities still have unsecured and un-encrypted laptops, which are susceptible to cybersecurity attacks. A report from a cybersecurity protection organization stated that a majority of high-risk scenarios that occur in health care entities were due to unsecure laptops. These unsecured laptops can lead to massive data breaches and can result in hefty fines imposed by the Office of Civil Rights. Proper encryption, tracking software, and rarely leaving laptops unattended are a few ways that employees and organizations can help safeguard protected health information and prevent data breaches.
Cook County General Administrative Order 18-1 pertains to the Standard HIPAA Qualified Protective Orders (QPO) that will be permitted in Cook County. These orders will only be allowed for cases that are in litigation where the Plaintiff and Plaintiff’s counsel authorize disclosure of a litigants’ protected health information (PHI). It also requires all entities who received PHI to either return the documents to the Plaintiff or destroy them at the end of the case. These changes mean that Plaintiff’s attorneys will see a change in the handling of Plaintiff’s medical records and other documents covered under the QPO containing PHI.
On March 1, 2019, the College of Healthcare Information Management Executives (“CHIME”) sent a six-page letter to Congress which discussed how technology has impacted health care costs. CHIME believes that too much money is being allocated towards making sure that health care organizations are complying with the Office of Civil Rights (“OCR”) and the Department of Health and Human Services (“HHS”) requirements, while not enough resources are being given towards actually protecting against cybersecurity attacks. The letter contains multiple suggestions in which patient data could be better protected, such as incentivizing health care organizations to implement more cybersecurity safety measures. However, many of CHIME’s proposals would require Congress to amend multiple provisions in acts, such as the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”).
In 2014, Congress passed the Sunscreen Innovation Act in the hopes of encouraging innovation for new sunscreen ingredients. Recently, the United States Food and Drug Administration (FDA) proposed new regulations regarding over-the-counter sunscreens to keep up with recent scientific and safety information. This proposal will be available for ninety days from its announcement on February 21, 2019, and addresses safety concerns of common sunscreen ingredients. Further, the proposal addresses the labeling of sunscreen, trying to make it easier for consumers to identify the product information. While this proposal seeks to alleviate safety concerns, the regulation could potentially make it more difficult for new ingredients to be approved.