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? 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?
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
that has been disclosed pursuant to the individual’s right of access.
For instance, a covered entity is not permitted to deny an individual’s
right of access to their ePHI where the individual directs the
information to a third-party app because the app will share the
individual’s ePHI for research or because the app does not encrypt the
individual’s data when at rest. In addition, as discussed in a separate FAQ, the HIPAA Rules do not apply to entities that do not meet the definition of a HIPAA covered entity or business associate.
| Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research Covered Entity: Private Practice Issue: Impermissible Disclosure-Research A private practice physician who was the principal investigator of a clinical research study disclosed a list of patients and diagnostic codes to a contract research organization to telephone patients for recruitment purposes. The disclosure was not consistent with documents approved by the Institutional Review Board (IRB). The private practice maintained that the disclosure to the contract research organization was permissible as a review preparatory to research. Activities considered “preparatory to research” include: preparing a research protocol; developing a research hypothesis; ...read more |
| Tuesday, November 1, 2022 Modernizing Medicine Inc. (ModMed), an electronic health record (EHR) technology vendor located in Boca Raton, Florida, has agreed to pay $45 million to resolve allegations that it violated the False Claims Act (FCA) by accepting and providing unlawful remuneration in exchange for referrals and by causing its users to report inaccurate information in connection with claims for federal incentive payments. The Anti-Kickback Statute prohibits anyone from offering or paying, directly or indirectly, any remuneration — which includes money or any other thing of value — to induce referrals of items or services covered by Medicare, ...read more |
| HMO Revises Process to Obtain Valid Authorizations Covered Entity: Health Plans / HMOs Issue: Impermissible Uses and Disclosures; Authorizations A complaint alleged that an HMO impermissibly disclosed a member’s PHI, when it sent her entire medical record to a disability insurance company without her authorization. An OCR investigation indicated that the form the HMO relied on to make the disclosure was not a valid authorization under the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, the HMO created a new HIPAA-compliant authorization form and implemented a new policy that directs staff to obtain patient signatures ...read more |
| § 164.314 Organizational requirements. (a) (1) Standard: Business associate contracts or other arrangements. The contract or other arrangement required by § 164.308(b)(3) must meet the requirements of paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section, as applicable. (2) Implementation specifications (Required) - (i) Business associate contracts. The contract must provide that the business associate will - (A) Comply with the applicable requirements of this subpart; (B) In accordance with § 164.308(b)(2), ensure that any subcontractors that create, receive, maintain, or transmit electronic protected health information on behalf of the business associate agree to comply with the applicable requirements of ...read more |
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Blog Home
Newest Blog Entries
1/21/25 Understanding Business Associate Agreements
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?
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