On Sept. 6, 2017, the Centers for Medicare and Medicaid Services (CMS) issued an advanced copy of guidance to state survey agency directors that is intended to clarify how to determine whether a hospital seeking Medicare certification, or going through a continuing certification survey, is “primarily engaged in providing inpatient services” under the Social Security…

By many accounts, 2017 is the 35th anniversary of widely propagating computer viruses. The recent “WannaCry” and “NotPetya” ransomware outbreaks demonstrate that computer viruses (or more broadly, “malware”) are still evolving, developing, and posing new threats. But IT contracts don’t move at the same pace. Contract provisions that address computer virus risk have…

Last year in Universal Health Services, Inc. v. United States ex rel. Escobar et al. (discussed on this blog), the Supreme Court reminded litigants that the False Claims Act “is not an all-purpose antifraud statute.” In that case, the Court expanded upon the FCA’s materiality standard, calling it both “rigorous” and “demanding.” How…

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:

“Big data” in the education context refers to the massive amount of information collected by K-12 schools and higher education institutions on student socio-economics, race and sex, test performance, academic performance, graduation rates, behavior and a myriad of other data points and how they all interact with one another. Collecting and analyzing student data is…

Employers using the H-1B visa program should take note as additional site visits may be on the horizon.  U.S. Citizenship and Immigration Services (“USCIS”), part of the Department of Homeland Security, recently announced a new targeted approach to detect H-1B visa fraud and abuse and increased site visits of H-1B employers.

In selecting worksite…