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 →

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 →

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.).

Continue reading →

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 →

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)).

Continue reading →

by Kim Stanger

Last week, a Texas health system agreed to a $2,400,000 HIPAA settlement arising out of a hospital’s disclosure of a patient’s name in a press release. (See here). Last year, a New York hospital agreed to pay $2,200,000 for allowing media to film in its facilities. (See here ). Given these cases, it is a good time to review the HIPAA rules on disclosures to the media.

Protected Health Information. HIPAA applies to a patient’s protected health information (“PHI”), which includes any individually identifiable information concerning a patient’s health, healthcare or payment for their care. (45 CFR § 160.103). It includes the patient’s name or any other identifiable information even if additional details of treatment are not included. A provider may not avoid HIPAA by simply omitting the name; PHI includes any information “[w]ith respect to which there is a reasonable basis to believe the information can be used to identify the individual”. (Id.). Accordingly, details about an individual that would allow others to identify the individual are considered PHI even if the usual identifiers are omitted. PHI remains protected by HIPAA even if the information is widely known in the community or the patient has disclosed the information himself or herself.

Disclosures to Media. HIPAA generally prohibits healthcare providers from disclosing a patient’s protected health information to media unless either (i) the patient or their personal representative authorizes the disclosure, or (ii) the disclosure fits within a HIPAA exception. (45 CFR § 164.502).

1. Authorization. When seeking to disclose information to the media, the safest course is to obtain the patient’s or their personal representative’s written authorization to make the disclosure. Providers should ensure that the authorization clearly covers the information that will be disclosed, describes the purpose of the disclosure, and identifies the persons or entity permitted to make and receive the disclosure. (45 CFR § 164.508). For more information about valid authorizations, see https://www.hollandhart.com/valid-hipaa-authorizations-a-checklist. In addition to obtaining a HIPAA authorization, the provider may want to obtain a separate media release.

2. Response to Media Inquiries. HIPAA’s “facility directory” exception is often used to justify disclosures to news media, but it is very limited in scope. Under this exception, a provider may disclose certain limited information “for directory purposes”, i.e., to notify persons who inquire about the patient of the patient’s general condition and location in the facility. (45 CFR § 164.510(a)). To make the disclosure, the following standards must be met:

1. Disclosure is Consistent with Patient’s Wishes. The exception will only apply if either (i) the patient or personal representative “is informed in advance of the use or disclosure and has the opportunity to agree to or prohibit or restrict the use or disclosure” for directory purposes, or (ii) “[i]f the opportunity to object … cannot practicably be provided because of the individual’s capacity or an emergency treatment circumstance,” the provider concludes that the disclosure is “consistent with the prior expressed preference of the individual, if any” and the disclosure is “[i]n the individual’s best interest….” (45 CFR § 164.510(a)). The provider’s Notice of Privacy Practices likely contains a provision that notifies the patient that disclosures may be made for facility purposes unless the patient objects. For competent patients, the notice arguably provides the required “opportunity to agree to or prohibit” disclosures for facility purposes; however, the OCR has stated:
   The patient must be informed about the information to be included in the directory, and to whom the information may be released, and must have the opportunity to restrict the information or to whom it is disclosed, or opt out of being included in the directory. The patient may be informed, and make his or her preferences known, orally or in writing.

   (OCR FAQ here). If the patient objects, the provider may not make the disclosure. If the patient is incompetent, the provider will have to establish both (i) that the disclosure is consistent with the patient’s prior expressed preferences and (ii) that the disclosure is in the patient’s best interests. That may be difficult to do in the case of media disclosures, and virtually impossible if the provider has never treated the patient before.

2. Ask for Patient by Name. Assuming that disclosure is consistent with the patient’s wishes, disclosure for directory purposes may only be made “to persons who ask for the [patient] by name.” (45 CFR § 164.510(a)(1)(ii)(B)). Thus, providers may not disclose PHI in response to general media inquiries where media do not identify the patient by name.
3. Disclose Only Limited Information. If the foregoing conditions have been satisfied, the provider may only disclose the limited information set forth below (45 CFR § 164.510(a)(1)(i)):

1. 1. The patient’s name. Of course, the media already has the patient’s name because they can only obtain PHI if they asked for the patient by name.
   2. The individual’s location in the healthcare provider’s facility. Providers should not disclose the location in the facility if it would effectively disclose the nature of the patient’s treatment, e.g., the psychiatric unit, labor and delivery, or a drug and alcohol treatment facility.
   3. The individual’s condition described in general terms that does not communicate specific medical information about the individual, e.g., “fair, critical, stable, etc.” (65 FR 82521). The American Hospital Association has recommended the following one-word descriptions of a patient’s condition.

(AHA, HIPAA Privacy Regulations: Frequently Asked Questions, available here). The OCR has stated, “[t]he fact that a patient has been “treated and released,” or that a patient has died, may be released as part of the directory information about the patient’s general condition and location in the facility, provided that the other requirements at 45 CFR § 164.510(a) also are followed.” (OCR FAQ here).

To summarize, the “facility directory” exception may allow limited disclosures to the media, but it is difficult to satisfy all the necessary prerequisites, including patient notice and consent. Moreover, I question whether such disclosures to the media are really for “facility directory purposes”—the reason the exception exists. Finally, the exception does not require disclosures to the media; it merely allows the disclosures if the conditions are satisfied. Out of respect for their patient’s privacy, the patient’s best interests, and regulatory intent, providers may appropriately decide it is safer not to disclose PHI to the media, or to limit the disclosure, unless the patient or the patient’s personal representative expressly consents to such disclosures.

Media Access to or Filming in Treatment Areas. The provider’s primary duty is to care for his or her patients. Media access, if not managed in an appropriate way, may impede care along with violating patient privacy, including the privacy of patients who may not be the subject of the media inquiry. Per the OCR’s FAQ:

(OCR FAQ at https://www.hhs.gov/hipaa/for-professionals/faq/2023/film-and-media/index.html).

Remember Other Laws. HIPAA preempts less restrictive laws, but providers must comply with more restrictive privacy laws. It may be that state or other federal laws prohibit media disclosures even if HIPAA might allow them. For example, 42 CFR part 2 places stringent privacy requirements on federally assisted drug and alcohol treatment programs. Providers should consider other potentially applicable laws or common law duties before making any disclosure.

In short, when it comes to dealing with the media, it is generally safer to simply explain that federal and state law prohibits your disclosure of health information. If a disclosure is to be made or media access allowed, providers must take extreme caution to comply with the HIPAA rules.

For questions regarding this update, please contact:
Kim C. Stanger
Holland & Hart, 800 W Main Street, Suite 1750, Boise, ID 83702
email: kcstanger@hollandhart.com, phone: 208-383-3913

This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

by Kim Stanger

Healthcare providers are often confused by or misunderstand the rules governing the release of a patient’s information at the patient’s request. HIPAA allows certain disclosures without the patient’s written authorization, including disclosures to other providers or third party payers for purposes of treatment, payment, or healthcare operations; to family members or others involved in the patient’s care or payment if certain conditions are met; or for certain government or public safety concerns if regulatory requirements are satisfied. (45 CFR 164.502, 164.506, 164.510 and 164.512). Other disclosures generally require the patient’s consent or written authorization. (45 CFR 164.502). The rules for such written releases of information (“ROI’s”) differ depending on who is requesting the records and to whom the disclosure will be made.

1. Disclosures to the Patient or Personal Representatives. Under HIPAA and subject to limited exceptions, a patient or the patient’s personal representative¹ generally has a right to obtain a copy of the patient’s protected health information maintained in the patient’s designated record set.² (45 CFR 164.524(a)(1)). If the provider chooses, the provider may require such requests to be in writing so long as the provider informs the individual of the requirement. (45 CFR 164.524(b)(1)). The provider must produce the records in the form or format requested (e.g., paper or electronic format) if readily producible. (45 CFR 164.524(c)(2)). It is usually a good idea to require written requests to document the date, scope, and format of the request. Once received, the provider has 30 days to respond to the request. (45 CFR 164.524(b)(2)). Although the provider may respond immediately, it is usually a good idea to take some time to collect and review the requested records before responding, thereby ensuring that the records provided are accurate, complete, and do not contain inappropriate information. Providers may charge the patients or personal representatives a reasonable cost-based fee for the records. (45 CFR 164.524(c)(4); see article at https://www.hollandhart.com/charging-patients-for-copies-of-their-records-ocr-guidance). The patient’s right to access information generally includes all information in their designated record set, including records created by or received from other providers. (OCR, Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524, hereafter “OCR Guide” available here). Continue reading →