Does HIPAA specify how compliance is to be achieved?
No. HIPAA regulations give health-care organizations the decision to decide how they will implement HIPAA compliance. They are technology and software-neutral.
What is the difference between HIPAA-ready and HIPPA-compliant?
HIPAA-ready typically refers to software products used by healthcare providers, insurance companies and clearing houses that comply with HIPAA guidelines. HIPAA-compliant refers to the doctors, hospitals and insurance companies themselves that are in compliance with HIPAA regulations.
Who must comply with HIPAA privacy standards?
As required by Congress in HIPAA, the Privacy Rule covers:
- Health plans
- Health care clearinghouses
- Health care providers who conduct certain financial and administrative transactions electronically. These electronic transactions are those for which standards have been adopted by the Secretary under HIPAA, such as electronic billing and fund transfers.
These entities (collectively called “covered entities”) are bound by the privacy standards even if they contract with others (called “business associates”) to perform some of their essential functions. The law does not give the Department of Health and Human Services (HHS) the authority to regulate other types of private businesses or public agencies through this regulation. For example, HHS does not have the authority to regulate employers, life insurance companies, or public agencies that deliver social security or welfare benefits.
Generally, what does the HIPAA Privacy Rule require the average provider or health plan to do?
For the average health care provider or health plan, the Privacy Rule requires activities, such as:
- Notifying patients about their privacy rights and how their information can be used.
- Adopting and implementing privacy procedures for its practice, hospital, or plan.
- Training employees so that they understand the privacy procedures.
- Designating an individual to be responsible for seeing that the privacy procedures are adopted and followed.
- Securing patient records containing individually identifiable health information so that they are not readily available to those who do not need them.
Does the HIPAA Privacy Rule require a business associate to create a notice of privacy practices?
No. However, a covered entity must ensure through its contract with the business associate that the business associate’s uses and disclosures of protected health information and other actions are consistent with the covered entity’s privacy policies, as stated in covered entity’s notice. Also, a covered entity may use a business associate to distribute its notice to individuals.
Is a software vendor a business associate of a covered entity?
The mere selling or providing of software to a covered entity does not give rise to a business associate relationship if the vendor does not have access to the protected health information of the covered entity. If the vendor does need access to the protected health information of the covered entity in order to provide its service, the vendor would be a business associate of the covered entity.
Would business associate contracts in electronic form, with an electronic signature, satisfy the HIPAA Privacy Rule’s business associate contract requirements?
Yes, assuming that the electronic contract satisfies the applicable requirements of State contract law. The Privacy Rule generally allows for electronic documents, including business associate contracts, to qualify as written documents for purposes of meeting the Rule’s requirements.
However, currently, no standards exist under HIPAA for electronic signatures. In the absence of specific standards, covered entities must ensure any electronic signature used will result in a legally binding contract under applicable State or other law.
What do the HIPAA Privacy and Security Rules require of covered entities when they dispose of protected health information?
The HIPAA Privacy Rule requires that covered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information (PHI), in any form. See 45 CFR 164.530(c). This means that covered entities must implement reasonable safeguards to limit incidental, and avoid prohibited, uses and disclosures of PHI, including in connection with the disposal of such information. In addition, the HIPAA Security Rule requires that covered entities implement policies and procedures to address the final disposition of electronic PHI and/or the hardware or electronic media on which it is stored, as well as to implement procedures for removal of electronic PHI from electronic media before the media are made available for re-use. See 45 CFR 164.310(d)(2)(i) and (ii). Failing to implement reasonable safeguards to protect PHI in connection with disposal could result in impermissible disclosures of PHI.
May a covered entity hire a business associate to dispose of protected health information?
Yes, a covered entity may, but is not required to, hire a business associate to appropriately dispose of protected health information (PHI) on its behalf. In doing so, the covered entity must enter into a contract or other agreement with the business associate that requires the business associate, among other things, to appropriately safeguard the PHI through disposal. See 45 CFR 164.308(b), 164.314(a), 164.502(e), and 164.504(e). Thus, for example, a covered entity may hire an outside vendor to pick up PHI in paper records or on electronic media from its premises, shred, burn, pulp, or pulverize the PHI, or purge or destroy the electronic media, and deposit the deconstructed material in a landfill or other appropriate area.
How should home health workers or other workforce members of a covered entity dispose of protected health information that they use off of the covered entity’s premises?
The HIPAA Privacy Rule requires that covered entities develop and apply policies and procedures for appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information (PHI), including through final disposition. See 45 CFR 164.530(c). In addition, the HIPAA Security Rule requires that covered entities implement policies and procedures to address the final disposition of electronic PHI and/or the hardware or electronic media on which it is stored. See 45 CFR 164.310(d)(2)(i). The Rules are flexible and thus, do not specify particular types of disposal methods; however, covered entities must ensure that the disposal method reasonably protects against impermissible uses and disclosures of PHI and protects against reasonably anticipated threats or hazards to the security of electronic PHI. See 45 CFR 164.530(c)(2) and 164.306(a). Whatever the disposal method, a covered entity must ensure that appropriate workforce members, either working on the premises or off-site, receive training on and follow the disposal policies and procedures of the covered entity. See 45 CFR 164.530(b) and (i), as well as 164.306(a)(4) and 164.308(a)(5) with regard to electronic PHI. These policies and procedures could require, for example, that employees or other workforce members who use PHI off-site, including electronic PHI, return all PHI to the covered entity for appropriate disposal. Or, for example, if appropriate under the circumstances, a covered entity could give off-site workforce members the option of either properly shredding PHI in paper records themselves or returning the PHI to the covered entity for disposal. In cases where workforce members fail to comply with the covered entity’s disposal policies and procedures, the covered entity must apply appropriate sanctions. See 45 CFR 164.530(e).
Does the HIPAA Privacy Rule require covered entities to keep patients’ medical records for any period of time?
No, the HIPAA Privacy Rule does not include medical record retention requirements. Rather, State laws generally govern how long medical records are to be retained. However, the HIPAA Privacy Rule does require that covered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of medical records and other protected health information (PHI) for whatever period such information is maintained by a covered entity, including through disposal. See 45 CFR 164.530(c).
Can a patient have a friend or family member pick up a prescription for her?
Yes. A pharmacist may use professional judgment and experience with common practice to make reasonable inferences of the patient’s best interest in allowing a person, other that the patient, to pick up a prescription. See 45 CFR 164.510(b). For example, the fact that a relative or friend arrives at a pharmacy and asks to pick up a specific prescription for an individual effectively verifies that he or she is involved in the individual’s care, and the HIPAA Privacy Rule allows the pharmacist to give the filled prescription to the relative or friend. The individual does not need to provide the pharmacist with the names of such persons in advance.
Does the HIPAA Privacy Rule permit a doctor to discuss a patient’s health status, treatment, or payment arrangements with the patient’s family and friends?
Yes. The HIPAA Privacy Rule at 45 CFR 164.510(b) specifically permits covered entities to share information that is directly relevant to the involvement of a spouse, family members, friends, or other persons identified by a patient, in the patient’s care or payment for health care. If the patient is present, or is otherwise available prior to the disclosure, and has the capacity to make health care decisions, the covered entity may discuss this information with the family and these other persons if the patient agrees or, when given the opportunity, does not object. The covered entity may also share relevant information with the family and these other persons if it can reasonably infer, based on professional judgment, that the patient does not object.
Can my health care provider discuss my health information with an interpreter?
Yes. HIPAA allows your health care provider to share your health information with an interpreter who works for the provider to help communicate with you or your family, friends, or others involved in your care. If the interpreter is someone who does not work for your health care provider, HIPAA also allows your provider to discuss your health information with the interpreter so long as you do not object.
Do I have to give my health care provider written permission to share or discuss my health information with my family members, friends, or others involved in my care or payment for my care?
HIPAA does not require that you give your health care provider written permission. However, your provider may prefer or require that you give written permission. You may want to ask about your provider’s requirements.
Does a physician need a patient’s written authorization to send a copy of the patient’s medical record to a specialist or other health care provider who will treat the patient?
Can the personal representative of an adult or emancipated minor obtain access to the individual’s medical record?
The HIPAA Privacy Rule treats an adult or emancipated minor’s personal representative as the individual for purposes of the Rule regarding the health care matters that relate to the representation, including the right of access under 45 CFR 164.524. The scope of access will depend on the authority granted to the personal representative by other law. If the personal representative is authorized to make health care decisions, generally, then the personal representative may have access to the individual’s protected health information regarding health care in general. On the other hand, if the authority is limited, the personal representative may have access only to protected health information that may be relevant to making decisions within the personal representative’s authority. For example, if a personal representative’s authority is limited to authorizing artificial life support, then the personal representative’s access to protected health information is limited to that information which may be relevant to decisions about artificial life support.
Does the HIPAA Privacy Rule permit doctors, nurses, and other health care providers to share patient health information for treatment purposes without the patient’s authorization?
Does the HIPAA Privacy Rule permit a doctor, laboratory, or other health care provider to share patient health information for treatment purposes by fax, e-mail, or over the phone?
Can a physician’s office FAX patient medical information to another physician’s office?
The HIPAA Privacy Rule permits physicians to disclose protected health information to another health care provider for treatment purposes. This can be done by fax or by other means. Covered entities must have in place reasonable and appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information that is disclosed using a fax machine. Examples of measures that could be reasonable and appropriate in such a situation include the sender confirming that the fax number to be used is in fact the correct one for the other physician’s office, and placing the fax machine in a secure location to prevent unauthorized access to the information. See 45 CFR164.530(c).
If patients request copies of their medical records as permitted by the Privacy Rule, are they required to pay for the copies?
The Privacy Rule permits the covered entity to impose reasonable, cost-based fees. The fee may include only the cost of copying (including supplies and labor) and postage, if the patient requests that the copy be mailed. If the patient has agreed to receive a summary or explanation of his or her protected health information, the covered entity may also charge a fee for preparation of the summary or explanation. The fee may not include costs associated with searching for and retrieving the requested information. See 45 CFR 164.524.
If I believe that my privacy rights have been violated, when can I submit a complaint?
By law, health care providers (including doctors and hospitals) who engage in certain electronic transactions, health plans, and health care clearinghouses, (collectively, “covered entities”) had until April 14, 2003, to comply with the HIPAA Privacy Rule. (Small health plans had until April 14, 2004, to comply). Activities occurring before April 14, 2003, are not subject to the Office for Civil Rights (OCR) enforcement actions. After that date, a person who believes a covered entity is not complying with a requirement of the Privacy Rule may file with OCR a written complaint, either on paper or electronically. This complaint must be filed within 180 days of when the complainant knew or should have known that the act had occurred. The Secretary may waive this 180-day time limit if good cause is shown. See 45 CFR 160.306 and 164.534. OCR provides further information on its web site about how to file a complaint.
In addition, after the compliance dates above, individuals have a right to file a complaint directly with the covered entity. Individuals should refer to the covered entity’s notice of privacy practices for more information about how to file a complaint with the covered entity.