These days, news stations are frequently running stories concerning people being treated for COVID-19, the providers working tirelessly to care for them, and politicians visiting health care facilities for a first-hand look at the crisis. In response to the media interest, the Office for Civil Rights (OCR) issued guidance on May 5, 2020 to healthcare providers answering the question “Does the COVID-19 Public Health Emergency alter the HIPAA Privacy Rule’s restrictions on disclosures of protected health information to the media?” The guidance reminds them “that the HIPAA Privacy Rule does …
Tag Archives: PHI
U.S. Health & Human Services – Office of Civil Rights Issued Guidance Regarding HIPAA Privacy and Novel Coronavirus
The Office of Civil Rights (OCR) last month provided guidance and a reminder to HIPAA covered entities and their business associates regarding the sharing of patient health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule during an outbreak or emergency situation such as what we are all facing right now with the Novel Coronavirus (2019-nCoV) outbreak.…
OIG Audit Finds that Majority of Part D Providers Surveyed Used E1 Transactions for Potentially Inappropriate Purposes
The Centers for Medicare and Medicaid Services (CMS) requested an audit by the Office of Inspector General (OIG) of Medicare Part D eligibility verification transactions (E1) transactions. The OIG recently released its report which found that the majority of the providers evaluated used E1 transactions for some inappropriate purpose other than to bill for a prescription or to determine drug coverage billing order.
What are E1 transactions and why is this information disturbing?…
OCR Comments on Recent Ciox Case Vacating Certain Omnibus Rule Regulations and Guidance Relating to Fees for Providing Patient Records
The U.S. Department of Health and Human Services’s (HHS) Office for Civil Rights (OCR) issued an Important Notice Regarding Individuals’ Right of Access to Health Records through its email list serve on January 29, 2020. In the Notice, OCR addressed the recent memorandum Opinion issued in Ciox Health v. Azar, et al, No. 18-cv-00040 (D.D.C. January 23, 2020).
In that case, Ciox Health, LLC, a specialized medical records provider, had challenged certain provisions of the 2013 Omnibus Rule, including provisions pertaining to what can be charged for delivering records …
Jackson Health System Fined by OCR
The Office for Civil Rights (OCR) announced on October 23, 2019 that Jackson Health System (Jackson), a not-for-profit hospital system comprised of six hospitals, urgent care centers, nursing facilities, and primary care and specialty services based in Miami, Florida, has waived its right to a hearing and did not contest the findings set forth in the OCR’s Notice of Proposed Determination (NPD), and has agreed to pay the full civil monetary penalty assessed by OCR. This unusual step means that Jackson will pay the full fine of $2.15 million.
According …
For First Time Ever, Government Brings HIPAA Enforcement Action Alleging Violations of Right to Access Medical Records
On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual right to access health information under HIPAA. OCR entered into a settlement with Bayfront Health St. Petersburg (Bayfront) in response to allegations that it failed to provide a mother with timely access to medical records concerning her unborn child. Under the terms of a resolution agreement, Bayfront agreed to pay $85,000, and enter into a …
OCR Issues Five New HIPAA FAQs on Health Information Apps
On April 18, 2019, the Department of Health & Human Services Office for Civil Rights (OCR) issued five new FAQs addressing the applicability of HIPAA to the use of software applications (apps) by individuals to receive health information from their providers.
The new FAQs are available here under the Header “Access Right, Apps and APIs.”
In the FAQs, OCR:
- Emphasizes that an individual’s right to access her/his protected health information (“PHI” or “ePHI”) under HIPAA generally obligates a covered entity to send PHI to a designated app, even if the
Texas Health System MD Anderson Seeks 5th Circuit Review of HHS Determination that HIPAA Required Encryption of its ePHI
On April 8, 2019, The University of Texas MD Anderson Cancer Center (MDA) filed a petition with the U.S. Court of Appeals for the Fifth Circuit seeking review of a decision by the Department of Health & Human Services’s (HHS) Departmental Appeals Board (DAB) Appellate Division to uphold $4.35 million in civil money penalties (CMPs) assessed against MDA by HHS for alleged violations of HIPAA’s Security and Privacy Rules.
The DAB’s decision, issued on February 8, 2019, affirmed a 2018 decision by an Administrative Law Judge that sustained CMPs issued …
OCR Issues Request for Information Regarding Modification of HIPAA To Promote Care Coordination and Transition to Value-Based Care
On December 14, 2018 the Department of Health & Human Services Office for Civil Rights (OCR) published a Request for Information (RFI) soliciting public input on updates to regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA) with the goals of removing “regulatory obstacles” and decreasing “regulatory burdens” in furtherance of the health care industry’s transition to value-based care models.
In the RFI, OCR requests input on whether and how the HIPAA regulations (i) can be modified to remove regulatory obstacles and burdens to efficient care coordination and …
Advanced Care Hospitalists Settles with OCR for $500,000 for Alleged HIPAA Violations
The Office for Civil Rights has announced that it has settled with Lakeland, Florida based Advanced Care Hospitalists (ACH) for $500,000 for allegations of an impermissible disclosure of protected health information by one of its business associates. ACH provides contract internal medicine physicians to nursing homes and hospitals.
According to the press release, between November 2011 and June 2012, ACH engaged an individual who claimed to be a representative of Doctor’s First Choice Billings, Inc., which provides medical billing services. Although the individual used First Choice’s website and company affiliation, …
Dumpster Diving Leads to $100,000 Fine for Defunct Business Associate Due to Improper Disposal of Medical Records
On February 13, 2018, the HHS Office for Civil Rights (OCR) announced a $100,000 settlement with a court-appointed receiver representing Filefax, Inc. (Filefax) arising from the 2015 discovery of medical records that contained protected health information (PHI) of over two thousand individuals in a dumpster. Filefax, a now-defunct medical records moving and storage company located in Illinois, acted as a business associate under HIPAA.
OCR initiated an investigation in February, 2015, after receiving an anonymous complaint concerning medical records that had been discovered and delivered to a facility for shredding …
Recent OCR Settlements
The Office for Civil Rights (OCR) recently announced settlements with healthcare-related entities, including:
- The OCR entered into a settlement with The Center for Children’s Digestive Health (CCDH) for $31,000. CCDH is a small for-profit health care provider with seven locations in Illinois. The settlement arose out of an OCR compliance review initiated in August 2015 after an investigation of a CCDH business associate that stored inactive paper medical records for CCDH. While CCDH had been disclosing PHI to the vendor since 2003, neither party could produce a business associate agreement
Vanderbilt University Medical Center PHI Breached by Patient Transporters
Vanderbilt University Medical Center (VUMC) has announced that it will be sending breach notification letters to over 3,000 patients as a result of unauthorized access to PHI by two patient transporters.
According to the announcement, VUMC audited its medical records (as it is required to do by HIPAA), and found that two individuals who worked as patient transporters accessed 3,247 patient records between May of 2015 and December of 2016 and were unauthorized to do so. The information accessed included data from adults and minors, including names, dates of birth, …
21st Century Cures Act – Implications for Investigators and Research Sites
Below is a summary of some of the key provisions relevant to investigators and research sites included in the recently enacted, bipartisan 21st Century Cures Act, including human subjects protections and the privacy and security of health information used in clinical research. Among other requirements, the Act:
*requires the Department of Health and Human Services (HHS) to harmonize the U.S. Food and Drug Administration (FDA) Human Subjects Regulations with the HHS Human Subject Regulations (the Common Rule), which should help streamline research that falls under both sets of regulations;…
