Covered entities and those persons rendered accountable by general principles of corporate criminal liability may be prosecuted directly under 42 U.S.C. § 1320d-6
November 12 2022
Posted in: Covered Entity
SCOPE OF CRIMINAL ENFORCEMENT UNDER 42 U.S.C. § 1320d-6 Covered entities and those persons rendered accountable by general principles of corporate criminal liability may be prosecuted directly under 42 U.S.C. § 1320d-6, and the knowingly element of the offense set forth in that provision requires only proof of knowledge of the facts that constitute the offense. MEMORANDUM OPINION FOR THE GENERAL COUNSEL DEPARTMENT OF HEALTH AND HUMAN SERVICES AND THE SENIOR COUNSEL TO THE DEPUTY ATTORNEY GENERAL You have asked jointly for our opinion concerning the scope of 42 U.S.C. § 1320d-6 (2000), the criminal enforcement provision of the ...read more
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May a covered entity use or disclose protected health information for litigation?
November 12 2022
Posted in: Covered Entity
May a covered entity use or disclose protected health information for litigation? Answer: A covered entity may use or disclose protected health information as permitted or required by the Privacy Rule, see 45 CFR 164.502(a) (PDF); and, subject to certain conditions the Rule typically permits uses and disclosures for litigation, whether for judicial or administrative proceedings, under particular provisions for judicial and administrative proceedings set forth at 45 CFR 164.512(e) (GPO), or as part of the covered entity’s health care operations, 45 CFR 164.506(a) (PDF). Depending on the context, a covered entity’s use or disclosure of protected health information in ...read more
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When does the Privacy Rule allow covered entities to disclose protected health information to law enforcement officials?
November 12 2022
Posted in: Covered Entity
When does the Privacy Rule allow covered entities to disclose protected health information to law enforcement officials? Answer: The Privacy Rule is balanced to protect an individual’s privacy while allowing important law enforcement functions to continue. The Rule permits covered entities to disclose protected health information (PHI) to law enforcement officials, without the individual’s written authorization, under specific circumstances summarized below. For a complete understanding of the conditions and requirements for these disclosures, please review the exact regulatory text at the citations provided. Disclosures for law enforcement purposes are permitted as follows: To comply with a court order or ...read more
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Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI?
November 12 2022
Posted in: Covered Entity
Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI? This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. Yes. When an individual requests access to her PHI and the covered entity intends to charge the ...read more
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What is a covered entity’s obligation under the Breach Notification Rule if it transmits an individual’s PHI to a third party designated by the individual in an access request, and the entity discovers the information was breached in transit?
November 12 2022
Posted in: Covered Entity
What is a covered entity’s obligation under the Breach Notification Rule if it transmits an individual’s PHI to a third party designated by the individual in an access request, and the entity discovers the information was breached in transit? This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. ...read more
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Can a covered entity use existing aspects of the HIPAA Privacy Rule to give individuals the right to decide whether sensitive information about them may be disclosed to or through a health information organization (HIO)?
November 12 2022
Posted in: Covered Entity
Can a covered entity use existing aspects of the HIPAA Privacy Rule to give individuals the right to decide whether sensitive information about them may be disclosed to or through a health information organization (HIO)? Yes. To the extent a covered entity is using a process either to obtain consent or act on an individual’s right to request restrictions under the Privacy Rule as a method for effectuating individual choice, policies can be developed for obtaining consent or honoring restrictions on a granular level, based on the type of information involved. For example, specific consent and restriction policies could ...read more
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Can a covered entity refuse to disclose ePHI to an app chosen by an individual because of concerns about how the app will use or disclose the ePHI it receives?
November 12 2022
Posted in: Covered Entity
Can a covered entity refuse to disclose ePHI to an app chosen by an individual because of concerns about how the app will use or disclose the ePHI it receives? No. The HIPAA Privacy Rule generally prohibits a covered entity from refusing to disclose ePHI to a third-party app designated by the individual if the ePHI is readily producible in the form and format used by the app. See 45 CFR 164.524(a)(1), (c)(2)(ii), (c)(3)(ii). The HIPAA Rules do not impose any restrictions on how an individual or the individual’s designee, such as an app, may use the health information ...read more
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May a covered entity dispose of protected health information in dumpsters accessible by the public?
November 12 2022
Posted in: Covered Entity
May a covered entity dispose of protected health information in dumpsters accessible by the public? For example, depending on the circumstances, proper disposal methods may include (but are not limited to): Shredding or otherwise destroying PHI in paper records so that the PHI is rendered essentially unreadable, indecipherable, and otherwise cannot be reconstructed prior to it being placed in a dumpster or other trash receptacle.Maintaining PHI for disposal in a secure area and using a disposal vendor as a business associate to pick up and shred or otherwise destroy the PHI.In justifiable cases, based on the size and the ...read more
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Covered Entity Definition
November 12 2022
Posted in: Covered Entity
A Covered Entity is: A health plan. An individual or group plan that provides, or pays the cost of, medical care. Health plans include private entities (e.g., health insurers and managed care organizations) and government organizations (e.g., Medicaid, Medicare, and the Veterans Health Administration) A health care provider. A provider of health care services and any other person or organization that furnishes, bills, or is paid for health care in the normal course of business. Health care providers (e.g., physicians, hospitals, and clinics) are covered entities if they transmit health information in electronic form in connection with a transaction ...read more
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11/12/22 Modernizing Medicine Agrees to Pay $45 Million to Resolve Allegations of Accepting and Paying Illegal Kickbacks and Causing False Claims

11/12/22 Indian National Charged in $8 Million COVID-19 Relief Fraud Scheme

11/12/22 Former Hospital Employee Pleads Guilty To Criminal HIPPA Charges

11/12/22 Covered entities and those persons rendered accountable by general principles of corporate criminal liability may be prosecuted directly under 42 U.S.C. § 1320d-6

11/12/22 The Delaware Division of Developmental Disabilities Services Data Breach

11/12/22 OCR Settles Three Cases with Dental Practices for Patient Right of Access under HIPAA

11/12/22 HHS Issues Guidance on HIPAA and Audio-Only Telehealth

11/12/22 Five Former Methodist Hospital Employees Charged with HIPAA Violations

11/12/22 May a covered entity use or disclose protected health information for litigation?

11/12/22 When does the Privacy Rule allow covered entities to disclose protected health information to law enforcement officials?

11/12/22 Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI?

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November 2022 (54)

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