Health Information Highlight

Welcome back to our three-part series examining ways to efficiently identify, address and mitigate gaps in HIPAA compliance in transaction diligence. In Part I of this series, we discussed four key diligence questions upon which buyers should focus their efforts in a transaction. Here, we review considerations related to storage of

Health Information Highlight

Welcome to a three-part series that will examine several ways to efficiently identify, address, and mitigate gaps in HIPAA compliance in transaction diligence.

A target’s value is often held in its information and people. An increased risk of HIPAA enforcement means that privacy and security diligence should not be a “check the

So far, 2018 has been a light year in terms of HIPAA enforcement.  There have been only two publicly-disclosed settlements.  But that doesn’t mean covered entities and business associates should let their guard down and assume that they don’t need to be mindful of HIPAA.  Indeed, it is hard to know what is going on

With 2017 having drawn to a close, it is once again time for HIPAA covered entities to complete their annual breach reporting obligations to the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”). Whereas covered entities must report breaches involving 500 or more individuals no later than 60 calendar days from

Drug adherence programs have significantly evolved over the last few years with drug companies, health plans, and providers taking steps to monitor patient medication compliance. Drug adherence is the degree to which a patient complies with medication administration advice for treatment of chronic disease. Beyond the obvious benefits to patients’ health and health entities’ bottom lines, drug adherence can have a large effect on public health and social communities. Therefore, although it is no surprise that the health care industry has turned its focus to adherence in a big way, it may be surprising that in an industry where confidentiality is king, the most recent strategy may be turning to big brother.

U.S. Food & Drug Administration Announcement

This past November, the U.S. Food & Drug Administration (“FDA”) announced approval of a new solution to medication noncompliance – digital tracking. The FDA has not broadly blessed the practice, which has been around since 2012, but rather took a large leap in that direction by approving the digital drug Abilify MyCite – a collaboration between drug manufacturer Otsuka and technology company Proteus Digital Health. The drug is used for the treatment of schizophrenia, episodes associated with bipolar I disorder, and certain depression diagnoses in adults, and Abilify MyCite, specifically, uses an ingestible sensor embedded in the drug tablet to trigger an electrical signal upon reacting with stomach acids. The signal is sent to a wearable patch and a mobile application, which records that medication was taken. The medication compliance can be tracked by patient relatives and caregivers so that they may directly access the information through a similar application or web-based portal.[1]

Privacy Concerns and Obtaining Consent

As the industry looks to improve public health and reduce health care costs (medication noncompliance is estimated to cost $100 billion/year in the U.S.), it works to balance the need to uphold patient rights, including patient privacy, especially where disease increases patients’ vulnerability. While HIPAA and state laws generally allow the access to and disclosure of patient information with consent as well as for treatment purposes,[2] regulation regarding this kind of monitoring by third parties and resulting use of the data is less explicit. Just as states are beginning to take a stronger stance on protection of biometric and genetic information, digital drugs and medication compliance may be next to receive additional scrutiny and increased protections.
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The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently issued guidance emphasizing the increased risks of using mobile devices in the workplace when the mobile devices contain or have access to sensitive data. Particularly, OCR warns of the risks of the use of mobile devices by healthcare organizations when the mobile devices are used to create, receive, maintain or transmit electronic protected health information (“ePHI”) that is protected by the Health Insurance Portability and Accountability Act (“HIPAA”).

Under the HIPAA Security Rule, covered entities and their business associates are required to conduct a risk analysis of the organization’s security risks and vulnerabilities and address identified vulnerabilities. OCR highlights that compliance with the Security Rule requires organizations to include mobile devices in the risk analysis and to address the inherent risks “to a reasonable and appropriate level.” A significant portion of reported settlements of alleged HIPAA claims have involved lost or stolen mobile devices that were not addressed in a risk assessment or not appropriately secured. In some cases, settlements for alleged non-compliance involving mobile devices have exceeded $2 million.

In addition to their inherent risk of being lost or stolen, OCR notes the following risks of using mobile devices to store or transmit ePHI:
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HIPAA’s Security Rule requires that Covered Entities perform “periodic” Security Risk Assessments. All too often, however, this regulatory obligation is ignored altogether, performed extremely sporadically, or treated as a regulatory hoop-jumping exercise to be completed as quickly as possible.  Aside increasing the risk of HIPAA liability, treating the Security Rule Risk Assessment in these ways

There are inherent risks in any vendor relationship. In the healthcare industry, with myriad regulatory pitfalls, the stakes can be even higher. Several customers of the cloud-based electronic health record (EHR) software vendor eClinicalWorks were relieved by a recent decision in which regulators decided not to take action against them as a result of the

The U.S. Department of Health & Human Services (HHS) issued a recent report noting that cybersecurity is a key public health concern that needs “immediate and aggressive attention.”  Shortly thereafter, HHS’ Office for Civil Rights (OCR) released a checklist of practical steps health care providers can take to protect themselves and their patients in the event of a cyber attack.  Both items underscore the Government’s increased focus on cybersecurity in the health care industry and remind health care providers of the importance of preparing for and appropriately responding to cyber attacks.

The Report

The interdisciplinary Health Care Industry Cybersecurity (HCIC) Task Force issued its 87 page report (the Report), mandated by the Cybersecurity Act of 2015, emphasizing the increased responsibility health care organizations have to secure their systems, medical devices, and patient data.

The increased focus on cybersecurity comes in the wake of recent rise and sophistication of cyberattacks on the health care industry. For instance, the Report notes that the health care sector experienced more cyber incidents resulting in data breaches in 2015 than any of the other 15 critical infrastructure sectors in the U.S. economy.  As the health care industry increasingly shifts to electronic health records (EHRs), automated medication delivery systems, and generally more connectivity and dependence on the Internet of Things (IoT), the prevalence and severity of these attacks is likely to increase.

The Report includes several high-level recommendations to federal regulators that could have a significant impact on members of the health care industry, including, among others:

  • Creating a cybersecurity leader role within HHS to align industry-facing efforts for health care cybersecurity;
  • Requiring federal regulatory agencies to harmonize existing and future laws and regulations that affect health care industry cybersecurity;
  • Exploring potential impacts to the Physician Self-Referral Law (the Stark Law), Anti-Kickback Statute, and other fraud and abuse laws to allow health care organizations to share cybersecurity resources and information with their partners; and
  • Establishing a Medical Computer Emergency Readiness Team (MedCERT) to coordinate medical device-specific responses to cybersecurity incidents and vulnerability disclosures.The Report also identified several recommended steps for industry members, including identifying a cybersecurity leadership role for driving for more robust cybersecurity policies, processes, and functions with clear engagement from executives.

The Report also suggested creating managed security service provider models to support small and medium-size health care providers. The Task Force also recommended that the industry evaluate options to migrate patient records and legacy systems to secure environments (e.g., hosted, cloud, shared computer environments). The imperatives, recommendations, and action items identified in the Report may be a guidebook for future rule-making from HHS aimed at strengthening the privacy of protected health information (PHI) in a new age of cybersecurity risks.

OCR Checklist

In the wake of the Report and an unprecedented year of increased cyber-attacks against health care entities (including the recent WannaCry attack and the Petya attack), OCR released a checklist of steps that HIPAA covered entities and business associates must take in response to a cyber-related security incident. OCR also published an infographic of the steps, which include:
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