On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released a four-volume cybersecurity guidance document for healthcare organizations. The publication, “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP), is the result of a government and industry collaboration mandated by the Cybersecurity Act of 2015. The HICP is not limited to individually identifiable health information but instead covers organizations’ enterprise-level information security more generally. HHS describes the publication as “practical, understandable, implementable, industry-led, and consensus-based voluntary cybersecurity guidelines to cost-effectively reduce cybersecurity risks for healthcare organizations of varying sizes.” Notwithstanding their voluntary nature, these HHS-backed cybersecurity recommendations are likely to serve as an important reference point for the industry. (more…)
On Thursday, August 4, 2016, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that Advocate Health Care Center (Advocate Health) agreed to pay $5.55 million to settle multiple violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is the largest HIPAA settlement to date against a single entity, and according to OCR, is due to the severity of the HIPAA violations and the length of time that those violations were allowed to persist. OCR alleged that in some instances, the purported violations date back to the effective date of the HIPAA Security Rule.
On June 24, 2016, Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”) entered into a resolution agreement with the Department of Health and Human Services Office for Civil Rights (“OCR”) to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule after the theft of a CHCS mobile device compromised the protected health information (“PHI”) of 412 nursing home residents. This is OCR’s first settlement with a HIPAA business associate. As part of the settlement, CHCS agreed to enter into a two-year corrective action plan (“CAP”) and pay a monetary penalty of $650,000.
On February 3, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that an HHS administrative law judge (ALJ) ordered Lincare, Inc., a home health provider of respiratory care, infusion therapy and medical equipment, to pay $239,800 in civil monetary penalties (CMPs) for violating the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The violations were disclosing patient information to an unauthorized person, failing to take reasonable safeguards to protect patient information from unauthorized disclosure and failing to implement adequate policies and procedures to protect patient information removed from its offices. This marks only the second time that OCR has imposed CMPs for HIPAA violations.
On December 28, 2015, President Obama signed into law S. 2425, the Patient Access and Medicare Protection Act (the “Act”). In addition to provisions intended to ensure that Medicare reimbursement policies promote continued access to certain durable medical equipment, like wheelchair accessories, the Act includes provisions that affect adoption of Health Information Technology (“HIT”) and those that provide greater protection against medical identity theft. Specifically, the Act recognizes various categories of hardship exceptions from meaningful use requirements for the 2015 reporting period and strengthens the penalties associated with medical identity theft.
On Monday, October 5, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released an online platform for mobile health developers and others interested in the intersection of information technology and health information privacy and security. Interested parties can submit questions and comments on issues related to compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The White House is soliciting public comments on its Proposed Privacy and Trust Principles (the Proposed Principles) for the Precision Medicine Initiative (PMI). PMI is a federal initiative to support research, technology and policies that enable the development of individualized treatments, and is backed by a $215 million investment under President Obama’s 2016 Budget.