Category Archives: HIPAA

January 23, 2019

Identifying Business Associates: Make Sure You Have BAAs in Place

by Kim Stanger

Failing to have HIPAA business associate agreements (“BAAs”) can result in significant penalties for healthcare providers and business associates. Last month, the OCR imposed a $500,000 settlement and robust corrective action plan against a physician group that failed to have a BAA with its billing company. After the billing company improperly allowed access to protected health information on its website, the OCR looked to the physician group to pay the price. (See https://www.hhs.gov/about/news/2018/12/04/florida-contractor-physicians-group-shares-protected-health-information-unknown-vendor-without.html).

Under HIPAA, “business associates” are essentially those entities who create, access, maintain or transmit PHI on behalf of a healthcare provider. (45 CFR § 160.103, definition of “business associate”). HIPAA requires healthcare providers to execute a BAA before disclosing protected health information (“PHI”) to their business associate. (45 CFR § 164.502(e)). It also requires business associates to execute a BAA with their subcontractors who handle PHI on behalf of the business associate. (Id.). The BAA must contain certain required terms. As recent settlements confirm, healthcare providers who fail to execute a BAA are subject to HIPAA penalties and may be vicariously liable for their business associate’s misconduct.

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January 8, 2019

HIPAA Breach Notification: When and How to Self-Report

by Kim Stanger

So you just discovered that protected health information (“PHI”) from your organization was improperly accessed or disclosed. Are you required to self-report the violation to the affected individual and HHS?

HIPAA Breach Notification Rule. Not all HIPAA violations are required to be reported to the relevant patient or HHS. Under the breach notification rule, covered entities are only required to self-report if there is a “breach” of “unsecured” PHI. (45 CFR § 164.400 et seq.).

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October 31, 2018

Department of Health & Human Services Upgrades Security Risk Assessment Tool

By Kim Stanger, Steven Lau, and Romaine Marshall

Under the Health Information Privacy and Portability Act (HIPAA), “covered entities” (generally speaking health care providers and their business associates) must all complete a risk assessment to identify and mitigate potential security risks (45 C.F.R. 164.308(a)(1)(ii)(A)). As many companies and providers have discovered, completing a risk assessment is time and resource-intensive and can be an overwhelming and expensive undertaking. Continue reading

October 22, 2018

Handling HIPAA Breaches: Investigating, Mitigating and Reporting

by Kim Stanger

HIPAA privacy and security violations can result in fines of $110 to $55,100 to covered entities (including healthcare providers and health plans) and their business associates. (45 CFR 160.404). If the violation resulted from “willful neglect”, the Office for Civil Rights (“OCR”) must impose a mandatory fine of $11,002 to $55,100. (45 CFR 160.404). To make matters worse, covered entities and their business associates must self-report breaches of unsecured protected health information (“PHI”) to the affected individual and to HHS (45 CFR 164.400); failure to do so may constitute “willful neglect” resulting in mandatory fines. The good news is that the OCR may not impose a fine so long as the covered entity or business associate did not act with “willful neglect” and corrected the problem within 30 days. (45 CFR 160.410(b)).

Responding to Possible Breaches. Given the potential consequences, it is critical that covered entities and business associates respond appropriately to potential HIPAA breaches to avoid or minimize their liability. Below are steps that you may follow to help identify and timely respond to HIPAA breaches. Continue reading

October 10, 2018

Producing Records of Other Providers

by Kim Stanger

There is a common misunderstanding that healthcare providers may not or should not produce medical records that were created by another healthcare provider.

Under HIPAA, patients have a right to access all records that a provider maintains in a designated record set, i.e., documents the provider uses to make decisions about a patient’s healthcare or payment for healthcare. (45 CFR 164.524). This would generally include records the provider obtains or receives from other providers relating to the patient’s care. Thus, providers generally must produce such records in response to the patient’s request; failure to do so would violate HIPAA. The OCR published the following FAQ relevant to this issue:

A provider might have a patient’s medical record that contains older portions of a medical record that were created by another previous provider. Will the HIPAA Privacy Rule permit a provider who is a covered entity to disclose a complete medical record even though portions of the record were created by other providers?

Answer: Yes, the Privacy Rule permits a provider who is a covered entity to disclose a complete medical record including portions that were created by another provider, assuming that the disclosure is for a purpose permitted by the Privacy Rule, such as treatment. Continue reading

March 9, 2018

Minimizing Liability For Business Associate Misconduct

By Kim Stanger

Republished with permission from AHLA’s Physicians and Hospitals Law Institute. Original article appeared Feb. 5, 2018. 

Healthcare providers, health plans and healthcare clearinghouses (“covered entities”) and business associates are subject to significant penalties for violations of the HIPAA Privacy, Security and Breach Notification Rules. To make matters worse, covered entities may be liable for their business associates’ misconduct, and business associates may be liable for their subcontractors’ violations. Covered entities and business associates must take appropriate steps to minimize exposure for their business associates’ or subcontractors’ violations. Continue reading

February 20, 2018

Producing Patient Records: The “Designated Record Set,” the “Legal Health Record,” and Records Created by Other Providers

Healthcare providers often misunderstand their obligation to provide patient records in response to a request from a patient or third party.

1. Patient Requests and the “Designated Record Set.” With very limited exceptions,[1] patients and their personal representatives generally have a right to access and/or require the disclosure of protected health information in the patient’s designated record set. (45 CFR § 164.524(a)). HIPAA defines “designated record set” as:

A group of records maintained by or for a covered entity that is:
(i) The medical records and billing records about individuals maintained by or for a covered health care provider; [or]
(iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals.

(45 CFR § 164.501). As the OCR recently summarized:

The Privacy Rule generally requires HIPAA covered entities (health plans and most health care providers) to provide individuals, upon request, with access to the protected health information (PHI) about them in one or more “designated record sets” maintained by or for the covered entity. This includes the right to inspect or obtain a copy, or both, of the PHI, as well as to direct the covered entity to transmit a copy to a designated person or entity of the individual’s choice. Individuals have a right to access this PHI for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created; whether the information is maintained in paper or electronic systems onsite, remotely, or is archived; or where the PHI originated (e.g., whether the covered entity, another provider, the patient, etc.).

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January 9, 2018

Reporting HIPAA Breaches: Annual Deadline Approaches

By Kim Stanger

The HIPAA breach notification rule requires covered entities to report breaches of unsecured protected health information (“PHI”) to affected individuals, HHS and, in some cases, local media. (45 CFR § 164.400 et seq.). The notice must be sent to individuals as soon as reasonably possible but no later than 60 days after it was discovered. (45 CFR § 164.404). The timing of notice to HHS depends on the number of persons affected by the breach: if the breach involves 500 or more persons, the covered entity must notify HHS at the same time it notifies the individual; if the breach involves less than 500 persons, the covered entity must report the breach to HHS until no later than 60 days after the end of the calendar year, i.e., by March 1. (45 CFR § 164.408(b)-(c)).

Is Your HIPAA Breach Reportable? Under the breach notification rule, covered entities are only required to self-report if there is a “breach” of “unsecured” PHI. (45 CFR § 164.400 et seq.). Continue reading

September 26, 2017

Police, Providers, Patients and HIPAA

By Kim Stanger

Recent cases have highlighted the conflict that may occur when police seek access to patients or patient information. Here are some general guidelines for physicians and other healthcare providers when facing demands from police or other law enforcement officials.

Disclosing Patient Information. The HIPAA privacy rules (45 CFR § 164.501 et seq.) generally prohibit healthcare providers from disclosing protected health information to law enforcement officials without the patient’s written authorization unless certain conditions are met. HIPAA allows disclosures for law enforcement purposes in the following cases:

  1. Court Order, Warrant, Subpoena, or Administrative Process. A provider may disclose information in response to a court order, warrant, subpoena or other administrative process if certain conditions are satisfied. (45 CFR § 164.512(f)(1)(ii)). These situations are discussed more fully in our separate client alert here.
  2. Avert Harm. A provider may disclose information to law enforcement to prevent or lessen a serious and imminent threat to the health or safety of an individual or the public. (45 CFR § 164.512(j)(1)(i)). Many states have specific statutes authorizing or requiring providers to make disclosures when credible threats are made against third parties.
  3. Required by Law. A provider may disclose information to law enforcement when a law requires the disclosure, e.g., to report child or adult abuse or neglect, injuries from gunshots or criminal activity, etc. Providers should comply with the strict terms of the law, and not disclose more than is required by the law. (45 CFR § 164.512(a), (f)(1)(i); see also § 164.512(b)(1)(ii) (child abuse) and § 164.512(c) (adult abuse)).
  4. Facility Directory. HIPAA generally allows, but does not require, providers to disclose limited information to persons who ask for a patient by name unless the patient has objected to such disclosures or the provider believes that the disclosure is not in the patient’s best interests. (See 45 CFR § 164.510). The provider may only disclose the patient’s name, general condition, and location in the facility. (Id.).
  5. Identify Person. If law enforcement requests information to help identify or locate a suspect, fugitive, material witness or missing person, a provider may disclose the following limited information: name and address, date and place of birth, social security number, ABO blood type and rh factor, type of injury, date and time of treatment, date and time of death, and a description of distinguishing physical characteristics. Other information related to the individual’s DNA, dental records, body fluid or tissue typing, samples, or analysis cannot be disclosed under this provision, but may be disclosed in response to a court order, warrant, or written administrative request. (45 CFR § 164.512(f)(2)). The disclosure must be in response to a request from law enforcement, which may include a response to a “wanted” poster or bulletin.
  6. Victim of a Crime. If law enforcement requests information about a person who is suspected of being a victim of a crime, a provider may disclose information if: (a) the individual agrees to the disclosure, or (b) the officer represents that the information is necessary to determine whether someone other than the victim has committed a crime, the information will not be used against the victim, the information is needed immediately and the law enforcement activity would be adversely affected by waiting to obtain the victim’s agreement, and the provider determines it is in the victim’s best interest to disclose the information. (45 CFR § 164.512(f)(3)).
  7. Death. A provider may disclose information to notify law enforcement about the death of an individual if the provider believes the death may have resulted from a crime.
  8. Crime on Premises. A provider may disclose information to law enforcement if the provider believes the information evidences criminal conduct on the provider’s premises. (45 CFR § 164.512(f)(5)).
  9. Crime Away from Premises. If, in the course of responding to an off-site medical emergency, providers become aware of criminal activity, they may disclose certain information to police as necessary to alert law enforcement to the criminal activity, including information about the commission and nature of the crime, the location of the crime or any victims, and the identity, description, and location of the perpetrator of the crime. (45 CFR § 164.512(f)(6)).
  10. Report by Victim. If a person affiliated with the provider is the victim of a crime, the person may disclose information necessary to report the crime to law enforcement; however, the person may only disclose the limited information listed in 45 CFR § 164.512(f)(2)(i). (45 CFR § 164.502(j)(2)).
  11. Admission of Violent Crime. If a person has admitted participation in a violent crime that a provider reasonably believes may have caused serious physical harm to a victim, a provider may disclose information to law enforcement necessary to identify or apprehend the person, provided that the admission was not made in the course of or based on the individual’s request for therapy, counseling, or treatment related to the propensity to commit this type of violent act. (45 CFR § 164.512(j)(1)(ii)(A), (j)(2)-(3)).
  12. Fugitive. A provider may disclose information to law enforcement to identify or apprehend an individual who appears to have escaped from lawful custody. (45 CFR § 164.512(j)(1)(ii)(B)).
  13. Prisoners. If law enforcement or a correctional institution requests protected health information about an inmate or person in lawful custody, a provider may disclose information if police represents such information is needed to provide health care to the individual; for the health and safety of the individual, other inmates, officers or employees of or others at a correctional institution or responsible for the transporting or transferring inmates; or for the administration and maintenance of the safety, security, and good order of the correctional facility, including police on the premises of the facility. (45 CFR § 164.512(k)(5)).
  14. Medical Examiners and Coroners. A provider may disclose information about a decedent to medical examiners or coroners to assist them in identifying the decedent, determining the cause of death, or to carry out their other authorized duties. (45 CFR § 164.512(g)(1)).

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