Southwest Acupuncture College /PWFNCFS

Transcription

1 Southwest Acupuncture College /PWFNCFS This replaces policies in the catalogue and any other documents to date. Boulder Santa Fe

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3 TABLE OF CONTENTS STATEMENT OF PURPOSE... 1 I. RIGHT TO A NOTICE OF PRIVACY PRACTICES... 1 Patient s right to notice... 1 Basic notice requirements... 1 II. PROVISION OF THE NOTICE TO PATIENTS... 1 General rules... 1 Electronic notice... 1 III. REVISIONS TO THE NOTICE... 2 The right to change the Notice Making material changes to the Notice... 2 Implementation of revised privacy practices... 2 IV. DOCUMENT RETENTION REQUIREMENTS... 2 AUTHORIZATION FOR USE OR DISCLOSURE OF PHI... 2 POLICY... 2 PURPOSE... 3 I. WHEN AN AUTHORIZATION IS REQUESTED... 3 II. CONTENT REOUIREMENTS... 3 Plain language... 3 Core elements... 3 Required notifications... 4 Authorization for marketing... 4 Copy to the patient... 4 Non-required elements... 4 Defective authorizations... 4 Combining documents... 5 III. REVOCATION OF AUTHORIZATIONS... 5 IV. RECORD RETENTION REQIREMENTS... 5 GENERAL USE AND DISCLOSURE... 5 POLICY... 5 PURPOSE... 5 I. INTRODUCTION... 5 Basic rule for use and disclosure of PHI... 5 Permitted uses and disclosures... 5 Incidental uses and disclosures... 6 Required disclosures... 6 II. MINIMUM NECESSARY... 6 The minimum necessary standard... 6 Exceptions... 6 Required policies and procedures for uses of PHI... 6 Required policies and procedures for disclosures of PHI... 7 Requests for PHI... 7 Reasonable reliance on requested disclosures... 8 III. DE-IDENTIFICATION... 8 Basic standard... 8 De-identifying information... 8 Use of PHI to create de-identified information... 8 Re-identification... 8 IV. DISCLOSURES TO FRIENDS AND RELATIVES... 8 Basic rule... 8 Disclosures of PHI when the patient is present... 9 Disclosures of PHI when the patient is not present... 9

4 V. ORAL COMMUNICATIONS... 9 Applicability of privacy standards... 9 Use of PHI in oral communications Documentation of oral communications The College s duty to safeguard PHI VI. DECEASED INDIVIDUALS VII. PERSONAL REPRESENTATIVES NATIONAL PRIORITY DISCLOSURES POLICY PURPOSE I. RELEASE OF PHI FOR NATIONAL PRIORITY PURPOSES General rule Specific situations where patient permission is not required II. VERIFICATION OF IDENTITY AND AUTHORITY Identity and authority Conditions on disclosures Identity of public officials Authority of public officials BUSINESS ASSOCIATES POLICY PURPOSE I. INTRODUCTION Need for business associate agreements General rules regarding business associates Limitations on the use of PHI Additional compliance obligations II. IDENTIFICATION OF A BUSINESS ASSOCIATE: Definition Workforce Treatment exception III. PROPOSED AGREEMENTS WITH BUSINESS ASSOCIATES Proposed business associate agreements Review of proposed agreements IV. REQUIRED ELEMENTS OF A BUSINESS ASSOCIATE AGREEMENT Optional provisions in the business associate contract V. PRIVACY VIOLATIONS COMMITTED BY A BUSINESS ASSOCIATE Employee s duty to notify Review of alleged violations Investigation and resolution of violations MARKETING POLICY PURPOSE I. DEFINITION OF MARKETING Marketing defined Exceptions to the definition of marketing Examples of exceptions II. USE AND DISCLOSURE OF PHI FOR MARKETING PURPOSES General rule Exceptions to the general rule Format requirements Business associates and other third parties REQUESTING ADDITIONAL PRIVACY... 18

5 POLICY PURPOSE I. RIGHT TO REQUEST RESTRICTION OF USES AND DISCLOSURES Patient s right to request restrictions Agreeing to a restriction Terminating a restriction RIGHT TO ACCESS RECORDS POLICY PURPOSE I. RIGHT OF ACCESS TO PHI Basic right to access Written Requests Denials without an opportunity for review Denials with an opportunity for review Right to review of denial Verification I. RESPONDING TO A REOUEST FOR ACCESS Acting on the request Provision of access Denial of access III. DOCUMENTATION AND RECORD RETENTION REOUIREMENTS REQUESTING AMENDMENTS POLICY PURPOSE I. RIGHT TO AMENDMENT OF PROTECTED HEALTH INFORMATION Patient s right to amendment Accepting a patient s request for amendment Denying a patient s request for amendment Permissible reasons for denial Denial procedures Receiving a notice of amendment from other health care providers or health plans Time period for acting on requests II. DOCUMENTATION AND RECORD RETENTION REQUIREMENTS ACCOUNTING OF DISCLOSURES POLICY PURPOSE I. RIGHT TO AN ACCOUNTING OF DISCLOSURES Basic right to an accounting of disclosures Exceptions to the accounting requirement Suspension of accounting Time period for action Fees for providing an accounting II. REQUIRED CONTENTS OF AN ACCOUNTING OF DISCLOSURES Core elements Multiple disclosures III. RECORD RETENTION REQUIREMENTS Required documentation Retention period TRAINING POLICY PURPOSE... 27

6 I. PRIVACY TRAINING Initial training New workforce members Additional training Content of training Documentation requirements PATIENT COMPLAINTS POLICY PURPOSE I. GENERAL RULE Subject of complaints Documentation of complaints INTERNAL ENFORCEMENT POLICY PURPOSE I. GENERAL RULES II. EXAMPLES OF POSSIBLE SANCTIONS Student violations III. ACTIONS THAT MAY RESULT IN SANCTIONS... 31

7 STATEMENT OF PURPOSE It is the policy of Southwest Acupuncture College to provide patients with a HIPAA (Health Insurance Portability and Accountability Act) Notice of Privacy Practices upon their first visit. In addition, the college will post the Notice in a conspicuous location and will make the Notice available to all patients upon request. Southwest Acupuncture College does not engage in transmission of health information in electronic form including billing. The purpose of this policy is to explain: (I) the patient s right to a Notice, (2) the relevant procedures the college must follow when providing its Notice to patients, and (3) the requirements for documentation of and revisions to the college s Notice. I. RIGHT TO A NOTICE OF PRIVACY PRACTICES Patient s right to notice Patients have the right to adequate notice of: 1. The uses and disclosures of Personal Health Information (PHI) that the college may make; 2. The patient s rights with respect to PHI; and 3. The college s legal obligations regarding PHI. Basic notice requirements The Notice must be written in plain language and contain specified elements. If a use or disclosure is prohibited by state law, the Notice s description of such use or disclosure must reflect the more stringent state law. II. PROVISION OF THE NOTICE TO PATIENTS General rules The College must follow these rules for providing a paper copy of the Notice to patients and the public in general. 1. The College must make the Notice available upon request to any person, even if they are not current College patients. 2. The College must provide the Notice to the patient no later than the date that the College first provides service to the patient. The College may send the Notice to all of its patients at once, give the notice to each patient as he or she comes into the College or by any combination of these approaches. 3. The College must have the Notice available at the clinic for individuals to request to take with them. 4. The College must post the Notice in a clear and prominent location in the clinic where patients will be able to read it. Electronic notice The College may be required to provide its Notice electronically under certain circumstances. Southwest Acupuncture College Page 1

8 1. If the College maintains a web site that provides information about the College s services or benefits, it must prominently post its Notice on the web site and make the Notice available electronically through the web site. 2. If an individual receives an electronic Notice from the College, he or she still has the right to obtain a paper copy of the Notice from the College upon request. III. REVISIONS TO THE NOTICE The right to change the Notice. If the College wishes to reserve the right to change its privacy practices and apply the revisions to PHI previously created or retained, it must make a statement to that effect in the Notice. If the College does not make this statement, it may still change its privacy practices, but it can apply those revised practices only to PHI that it creates or obtains in the future, after the effective date of the change. Making material changes to the Notice The College must promptly revise and distribute its Notice whenever there is a material change to the uses or disclosures of PHI, the individuals rights, the College s legal obligations, or other privacy practices stated in the Notice. 1. Whenever the Notice is revised, the College must make the Notice available upon request on or after the effective date of the revision, promptly make the Notice available at the clinic, and post the revised Notice in a clear and prominent location in the clinic. 2. After giving a patient a copy of the Notice upon his or her first visit, the College is not required to further distribute the Notice to the patient. Even if the College revises the Notice, it is not required to distribute the Notice to all current and former patients. The College only has to make the Notice available upon request and post the information in the clinic. Implementation of revised privacy practices In general, the College may not implement a material change to any term of the Notice before the effective date of the Notice that reflects the material change. This means that the College must revise its Notice accordingly and make it available to patients before it may implement any new or different privacy practices. IV. DOCUMENT RETENTION REQUIREMENTS The College must retain a copy of each Notice it issues for a period of six years from the date that the Notice was last in effect. AUTHORIZATION FOR USE OR DISCLOSURE OF PHI POLICY The College will obtain a valid, signed authorization from a patient prior to using or disclosing the patient s PHI for purposes not otherwise permitted by a verbal agreement or the rules that allow uses or disclosures without the patient s permission. Southwest Acupuncture College Page 2

9 PURPOSE The purpose of this policy is to explain: (1) when a written patient authorization is required, and (2) the relevant procedures the College must follow when using or disclosing PHI pursuant to a valid authorization. I. WHEN AN AUTHORIZATION IS REQUESTED An authorization is required before the College uses or discloses PHI for non-routine purposes beyond treatment or health care operations, such as sales of PHI and certain marketing activities. Among the uses and disclosures for which an authorization is not required are uses and disclosures: 1. For treatment, payment, and health care operations. 2. For involvement in the patient s care and notification purposes. 3. Required by law. 4. For public health activities. 5. About victims of abuse, neglect, or domestic violence. 6. For health oversight activities. 7. For judicial and administrative proceedings. 8. For law enforcement purposes. 9. About decedents. 10. For research purposes where a waiver has been obtained. 11. To avert a serious threat to health or safety. 12. For specialized government functions. 13. For workers compensation. 14. To the patient. 15. To the Department of Health and Human Services for enforcement of the privacy rules. 16. For marketing communications that are made face-to-face or that involve promotional products of nominal value. II. CONTENT REOUIREMENTS Plain language All authorizations must be written in plain language. This means that the College must make a reasonable effort to: 1. Organize material to serve the needs of the reader. 2. Write short sentences in the active voice, using you and other pronouns. 3. Use common, everyday words in sentences. 4. Divide material into short sections. Core elements All authorizations must contain the following core elements: 1. A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion. 2. The name or other specific identification of the person(s) or class of persons authorized to make the requested use or disclosure. Southwest Acupuncture College Page 3

10 3. The name or other specific identification of the person(s) or class of persons to whom the College will disclose the information. 4. A description of each purpose of the requested use or disclosure with enough information to allow patients to make informed decisions about whether to release the information. Broad or blanket authorizations requesting the use or disclosure of PHI for a wide range of unspecified purposes are prohibited, but if the patient is initiating the authorization the purpose may be described as at the request of the individual. 5. An expiration date or an expiration event that relates to the patient or the purpose of the use or disclosure. The authorization may expire on a specific date, a specific time period (e.g., 3 years from the date of the signature), or an event directly relevant to the patient or the purpose of the use or disclosure (e.g., for the duration of the patient s participation in a drug study). Authorizations may not have an indeterminate expiration date. 6. Signature of the patient and the date. 7. If the authorization is signed by a personal representative of the patient, a description of the representative s authority to act for the patient. Required notifications In addition to the core elements, authorizations must contain all of the following notifications: 1. A statement that the patient has the right to revoke the authorization in writing and either a discussion of the exceptions to the right to revoke, together with a description of how the patient may revoke the authorization, or, to the extent that this information is included in the Notice of Privacy Practices, a reference to the Notice. 2. For most authorizations, a statement that the College will not condition treatment, payment, enrollment, or eligibility on the patient s providing authorization for the requested uses or disclosures. 3. A statement that information used or disclosed pursuant to the authorization may be subject to re-disclosure by the recipient and no longer be protected by the Privacy Regulations. Authorization for marketing If the authorization is for marketing purpose, and the marketing involves any direct or indirect remuneration to the College from a third party, the authorization must state this fact. The College does not use any PHI for marketing purposes. Copy to the patient The College must give the patient a copy of the signed authorization. Non-required elements Valid authorizations may also contain non-required elements, so long as those additional elements are not inconsistent with the required elements. Defective authorizations An authorization is not valid if it has any of the following defects: Southwest Acupuncture College Page 4

11 1. The expiration date has passed or the expiration event is known by the College to have occurred. 2. The required elements of the authorization have not been filled out completely. 3. The authorization is known by the College to have been revoked. 4. The authorization lacks a required element. 5. The authorization violates the rule on compound authorizations (see Section ll. H. below). 6. Any material information in the authorization is known by the College to be false. Combining documents An authorization for use or disclosure of PHI may not be combined with any other types of documents (e.g., The notice of privacy practices) to create a compound authorization. However, multiple authorizations for the use or disclosure of PHI may be combined, so long as the College has not conditioned the provision of treatment or payment on obtaining the authorization. III. REVOCATION OF AUTHORIZATIONS A patient may revoke an authorization at any time by means of a written revocation, except to the extent that the College has taken action in reliance upon the authorization. When a patient revokes an authorization, the College must stop making uses and disclosures pursuant to the authorization to the greatest extent practical. IV. RECORD RETENTION REQIREMENTS The College must document and retain signed authorizations for six years after the date they were last in effect. GENERAL USE AND DISCLOSURE POLICY The College will use and disclose PHI only as specifically permitted or required by the privacy rules in accordance with the College s privacy policies and procedures. PURPOSE The purpose of this policy is to explain the basic standards that must be met when using and disclosing PHI. I. INTRODUCTION Basic rule for use and disclosure of PHI The College may not use or disclose PHI unless permitted or required by the privacy rules. Permitted uses and disclosures Some of the permitted uses and disclosures of PHI are: 1. To the patient; 2. To carry out treatment, payment or health care operations; Southwest Acupuncture College Page 5

12 3. In compliance with a valid authorization; 4. Pursuant to a verbal agreement from a patient that permits disclosure to a caregiver; and 5. For certain national priority purposes such as disclosures required by law. Incidental uses and disclosures Incidental uses and disclosures that occur as a by-product of a use or disclosure otherwise permitted under the privacy rules are explicitly permitted, so long as the College has applied reasonable safeguards and implemented the minimum necessary standard, where applicable. Required disclosures The privacy rules require the College to disclose PHI in only two instances: 1. When the patient requests access to information about himself or herself; and 2. When HHS requests information to investigate or determine the College s compliance with the rules. II. MINIMUM NECESSARY The minimum necessary standard When using or disclosing PHI, and when requesting PHI from another entity, the College must make reasonable efforts to use, disclose or request the minimum amount of PHI reasonably necessary to accomplish the intended purpose of the use, disclosure or request. Exceptions Among the uses, disclosures, and requests to which the minimum necessary standard does not apply are: 1. Use and disclosure by health care provider for treatment purposes; 2. Disclosure to the patient who is the subject of the information, or the individual s personal representative; 3. Use or disclosure made pursuant to an authorization; 4. Disclosure to HHS when required for complaint investigation, compliance and enforcement purposes; 5. Use or disclosure that is required by law; and 6. Use or disclosure required for compliance with HIPAA Transactions Rule or other HIPAA Administrative Simplifications Rules. Required policies and procedures for uses of PHI The College must develop and implement policies that limit the use of PHI to the minimum PHI reasonably necessary to accomplish the intended purpose of the use or disclosure. 1. The policies and procedures for use of PHI must identify: a. The persons or classes of persons in the College who need access to PHI to carry out their duties; b. The categories of PHI that each person or class of persons needs; c. Any conditions necessary for such access. Southwest Acupuncture College Page 6

13 2. The College must have policies and procedures that limit access to only the identified persons and to only the identified PHI. These policies and procedures should be based on reasonable determinations about the persons or classes of persons who require PHI, and the nature of the PHI they require, for their particular job responsibilities. Required policies and procedures for disclosures of PHI The College also is required to develop certain policies and procedures for disclosures of PHI. The regulatory requirements differ depending on whether the disclosure is a routine or non-routine disclosure. 1. For any type of disclosure that is made on a routine, recurring basis, the College must develop and implement policies and procedures (which may be standard protocols) that permit only the disclosure of the minimum amount of PHI that is reasonably necessary to achieve the purpose of the disclosure. The policies and procedures must identify the: a. Types of PHI to be disclosed; b. Types of persons who may receive the PHI; and c. Conditions necessary for such access. 2. For non-routine disclosures, the College must develop reasonable criteria for determining and limiting disclosure to only the minimum amount of PHI necessary to accomplish the purpose of the disclosure. a. Among the factors that may be considered in making such a determination are: i. How much PHI will be disclosed? ii. To what extent would the disclosure increase the number of persons with access to the PHI? iii. What is the likelihood of further disclosures? iv. How important is the disclosure? v. Can substantially the same purpose be achieved using de-identified information? vi. Is there technology available to limit the amount of PHI disclosed? vii. What is the cost, financial or otherwise, of limiting the disclosure? b. The College must also develop and implement procedures for reviewing non-routine requests for disclosures on an individual basis in accordance with established criteria. Requests for PHI The minimum necessary standard applies to situations where the College is requesting an individual s PHI from another entity. 1. For requests to other entities made on a routine and recurring basis, the College must establish standard protocols describing what information is reasonably necessary for the purposes for which it is requested, and limit its requests to only that information. 2. For non-routine requests, the College must develop policies and procedures that provide for review of the requests on an individualized basis. Southwest Acupuncture College Page 7

14 Reasonable reliance on requested disclosures The College may rely, if reasonable under the circumstances, on statements by public officials or other covered entities or their business associates that they are requesting the minimum PHI necessary to achieve the stated purpose of the request. The College may also reasonably rely on the statements of its own business associates or professionals within its workforce (such as pharmacists, attorneys or accountants) that the information requested to provide professional services to the College is the minimum necessary for such purposes. III. DE-IDENTIFICATION Basic standard Health information is considered de-identified (i.e., not individually identifiable) under the rules if it does not identify a patient and the College has no reasonable basis to believe it can be used to identify a patient. De-identified information is not PHI and therefore the requirements of the rules do not apply to such information. De-identifying information The College may de-identify information in two ways: 1. If a person with appropriate knowledge and experience applying generally accepted statistical and scientific principles and methods for rendering information not individually identifiable makes a determination, and documents the analysis, that the risk is very small that the information could be used, either by itself or in combination with other available information, by anticipated recipients to identify a subject of the information; or 2. If the College removes a list of specified identifying information about the individual or his or her relatives, employers, or household members, and the College has no actual knowledge that the information could be used alone or in combination to identify a subject of the information. Use of PHI to create de-identified information The College may use PHI to create de-identified information, or may disclose PHI to a business associate for such purpose, whether or not the de-identified information will be used by the College. Re-identification If de-identified information is re-identified at some point by the College, it becomes subject to the rules again and may only be used or disclosed in compliance with the regulations and the College s privacy policies. IV. DISCLOSURES TO FRIENDS AND RELATIVES Basic rule The College may disclose to a person involved in the current health care of the patient (such as a relative, close personal friend, or any other person identified by the patient) PHI directly related to the person s involvement in the current health care of the patient or payment for the patient s health care. Examples of persons who might be involved in the patient s care include, but are not limited to: Southwest Acupuncture College Page 8

15 1. Blood relatives; 2. Spouses; 3. Roommates; 4. Girlfriends and boyfriends; 5. Domestic partners; and 6. Neighbors. Disclosures of PHI when the patient is present When the patient is present and has the capacity to make his or her own decisions, the College may disclose PHI to the third party only if the College: 1. Obtains the patient s agreement to disclose to the third party involved in his or her care; 2. Provides the patient with an opportunity to object to such disclosure and the patient does not express an objection; or 3. Reasonably infers from the circumstances, based on the exercise of professional judgment, that the patient does not object to the disclosure. Disclosures of PHI when the patient is not present When a patient is not present (e.g., when a friend of the patient seeks to pick up the patient s herbs at the College) or when the College cannot practically give the patient an opportunity to agree or object to the use or disclosure (e.g., because of the patient s incapacity or an emergency circumstance), the College may, in the exercise of professional judgment, determine whether the disclosure is in the patient s best interests and if so, disclose only the PHI that is directly relevant to the person s involvement with the patient s health care. For instance, this allows the clinic to disclose instructions for taking a particular herbal formula to an elderly patient s caregiver. The clinic must follow these guidelines when deciding whether to disclose PHI when the patient is not present: 1. Only disclose PHI that is directly related to the patient s current condition. 2. Consider the patient s best interests and construe this opportunity narrowly, allowing disclosures only to those persons with close relationships with the patient, such as family members. 3. Take into account whether the disclosure is likely to put the patient at risk of serious harm. 4. College employees are not required to verify the identity of relatives or other persons involved in the patient s care. 5. A patient s agreement to disclosure of PHI in one situation or on one occasion does not mean that the patient is agreeing to disclosures of PHI indefinitely in the future. Use professional judgment to determine the scope of the person s involvement in the patient s care and the time period during which the patient agrees to the other person s involvement. V. ORAL COMMUNICATIONS Applicability of privacy standards The rules apply to PHI in all forms electronic, written, oral, and any other form. Southwest Acupuncture College Page 9

16 Use of PHI in oral communications Employees may orally coordinate College services. Employees may discuss a patient s PHI over the telephone with the patient, or designated representative. Documentation of oral communications The College is not required to document any information, including oral information, which is used or disclosed for treatment, payment, or health care operations. However, where the rules or the College s privacy policies require documentation of other types of disclosures, oral communications are included in this requirement. For example, oral disclosures of PHI for purposes other than treatment, payment, or health care operations must be documented in order to provide the patient with a complete accounting of disclosures. The College s duty to safeguard PHI The College must reasonably safeguard PHI, including oral information, from any intentional or unintentional use or disclosures that are in violation of the rules or the College s privacy policies. This means that the College must make reasonable efforts to prevent improper uses and disclosures of PHI. Measures that the College may implement to protect patients privacy include: 1. Creating a private area, such as a small separate room, cubicle, or screened off or divided area, where the clinicians can counsel patients regarding treatment of their medical conditions. 2. Speaking quietly or asking that waiting patients stand a few feet back from the counter when College employees are consulting with patients from behind the College counter. VI. DECEASED INDIVIDUALS The College must protect the PHI of deceased individuals in accordance with the rules and the College s privacy policies for as long as the College maintains the information. VII. PERSONAL REPRESENTATIVES The College must treat a person as the personal representative of a patient if the person is, under applicable state or other law, authorized to act on behalf of the patient in making decisions related to health care. However, the representative must be treated as the patient only to the extent that PHI is relevant to the matters on which the personal representative is authorized to represent the patient. For instance, if the personal representative is authorized to act on the patient s behalf only with respect to the patient s treatment for cancer, then the College may disclose to the personal representative only that information that is relevant to the patient s cancer treatment. In addition, the personal representative s rights are limited by the scope of his or her authority under state or other law. NATIONAL PRIORITY DISCLOSURES POLICY The College may release PHI without a valid authorization or other permission from the patient if the use or disclosure falls within one or more of the national priority Southwest Acupuncture College Page 10

17 exceptions of the HIPAA privacy rules and the College has complied with all of the conditions required by the exception. PURPOSE The purpose of this policy is to explain the situations where a national priority exception to the HIPAA rules allows the College to use or disclose PHI without a written patient authorization or oral permission, and to describe the relevant procedures the College must follow when using or disclosing PHI in such situations. I. RELEASE OF PHI FOR NATIONAL PRIORITY PURPOSES General rule As discussed in the College s other HIPAA policies, in many circumstances, the College is allowed to use or disclose patient s PHI without their explicit prior permission. In addition to the situations described in those other HIPAA policies, the College is allowed to use and disclose PHI for particular national priority purposes without obtaining any form of permission (i.e., authorization or verbal agreement) from the patient. Specific situations where patient permission is not required Listed below are separate categories of uses and disclosures for which the College is not required to obtain affirmative permission from the patient prior to disclosure. 1. Required by law. The College may use or disclose PHI as required by law, if the use or disclosure complies with and is limited to the relevant requirements of such law. 2. Public health activities. The College may disclose PHI for the following public health activities: a. To a public health authority authorized by law to collect or receive information for the purpose of preventing or controlling disease, injury, or disability (e.g., reporting communicable diseases), and the conduct of public health surveillance, investigations or interventions; and b. To a person subject to FDA jurisdiction regarding FDA-regulated products and activities that are the responsibility of that person, for purposes related to quality, safety or effectiveness of that product or activity, including but not limited to: (i) collecting or reporting adverse events or product defects or problems such as labeling problems; (ii) tracking FDA-regulated products; (iii) enabling product recalls, repairs, or replacement (including locating and notifying individuals who received product that have been recalled or withdrawn, or that are the subject of lookback); or (iv) conducting post- marketing surveillance. 3. Health oversight activities. The College may disclose PHI to a health oversight agency for oversight activities authorized by law, including audits, investigations, inspections, licensure or disciplinary actions, civil, administrative, or criminal proceedings, or other activities necessary for the oversight of the health care system, government benefit programs, or civil rights laws. The College is permitted to respond to a health oversight agency s request for PHI as well as initiate these disclosures on its own. Southwest Acupuncture College Page 11

18 4. Judicial and administrative proceedings. The College may disclose PHI in the course of a judicial or administrative proceeding if the request for PHI is made pursuant to a court or administrative order or in response to a subpoena or discovery request (or other lawful process) from a party to the proceeding. a. If the request is made pursuant to a court or administrative order, the College may disclose the information requested without additional process. In such cases, the College may disclose only the information expressly authorized by the order. b. Without a court order or subpoena issued by a court, the College must take additional steps to ensure the confidentiality of the information before it is permitted to disclose the minimum PHI necessary to fulfill the request. 5. Law enforcement purposes. The College may disclose PHI for law enforcement purposes to a law enforcement official under certain enumerated circumstances. Certain limited information may be disclosed to a law-enforcement official: a. As required by other law or court order, warrant, subpoena, or administrative request; b. To identify or locate a suspect, fugitive, material witness, or missing person; c. In response to a request about an individual who may be a victim of a crime; d. About an individual who has died as a result of criminal conduct; or e. Where the College believes that the information constitutes evidence of criminal conduct that occurred on the premises of the College. 6. Specialized government functions. The College may disclose the PHI of armed forces personnel if necessary for a military mission. The College may also disclose PHI to federal officials for intelligence and national security activities, or to a law enforcement or correctional institution official who has custody of the individual and needs the information to provide health care to the individual or to protect the health and safety of others. 7. Workers compensation. The College may disclose PHI as necessary to comply with laws relating to workers compensation or similar programs. 8. Serious threat to health or safety. The College may disclose PHI if it believes in good faith that the disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public and the disclosure is to a person reasonably able to prevent the threat, or is necessary for law enforcement authorities to identify or apprehend an individual. II. VERIFICATION OF IDENTITY AND AUTHORITY Identity and authority With the exception of disclosures made pursuant to valid authorizations, prior to disclosing PHI the College must verify the identity of a person requesting the PHI and the authority of such person to access PHI requested, if the identity and/or authority is not known. Southwest Acupuncture College Page 12

19 Conditions on disclosures The College must obtain any documentation, statements, or representations, whether oral or written, from the person requesting the PHI that are a condition of disclosure under the privacy rules or other law (e.g., when making certain national priority disclosures). Identity of public officials The College may rely, if such reliance is reasonable under the circumstances, on any of the following to verify identity when the disclosure of PHI is to a public official or a person acting on behalf of the public official: 1. If the request is made in person, presentation of an agency identification badge, other official credentials, or other proof of government status. 2. If the request is in writing, the request is on the appropriate government letterhead. 3. If the disclosure is to a person acting on behalf of a public official, a written statement on appropriate government letterhead that the person is acting under the government s authority or other evidence or documentation of agency, such as a contract for services, memorandum of understanding, or purchase order, that establishes that the person is acting on behalf of the public official. Authority of public officials The College may rely, if such reliance is reasonable under the circumstances, on any of the following to verify authority when the disclosure of protected health information is to a public official or a person acting on behalf of the public official: 1. A written statement of the legal authority under which the information is requested, or, if a written statement would be impracticable, an oral statement of such legal authority. 2. If a request is made pursuant to legal process, a warrant, subpoena, order, or other legal process issued by a grand jury or a judicial or administrative tribunal. BUSINESS ASSOCIATES POLICY All agreements with business associates of the College must be in writing and must contain certain mandatory provisions designed to protect the privacy and security of our patients PHI. No College employee shall disclose PHI to a business associate without first obtaining a signed and dated business associate agreement. PURPOSE The purpose of this policy is to protect, through the execution and enforcement of written agreements, the privacy and confidentiality of PHI that the College discloses to individuals and entities that are business associates of the College, as defined by the rules. Southwest Acupuncture College Page 13

20 I. INTRODUCTION Need for business associate agreements From time to time, the College contracts with an individual or company to provide services to the College or on behalf of the College. If such a relationship involves sharing or providing access to PHI that the College maintains, then the College is required to enter into a written contract, known as a business associate agreement, with the individual or company. The primary purpose of the agreement is to ensure that the business associate will use or disclose the PHI for lawful purposes only. General rules regarding business associates The privacy rules define a business associate as a person or entity that provides certain functions, activities, or services to or for the College, involving the use or disclosure of PHI. The College may disclose PHI to a business associate, or allow the business associate to create or receive PHI on its behalf, so long as the College enters into a valid business associate agreement. Limitations on the use of PHI The business associate may only use the PHI that it receives in its capacity as the College s business associate as permitted by law and its contract with the College. Additional compliance obligations Disclosures of PHI to business associates must comply with all of the College s other policies and procedures. II. IDENTIFICATION OF A BUSINESS ASSOCIATE: Definition A business associate is a person or entity that: 1. On behalf of the College, performs or assists in the performance of functions or activities involving the use or disclosure of PHI. Examples of such functions include but are not limited to: Claims processing or administration. Data analysis, processing or administration. Utilization review. Quality assurance. Billing. Benefit management. Practice management. 2. Provides the following services to the College where the provision of services involves the disclosure of PHI: Legal. Actuarial. Accounting. Consulting. Data aggregation. Southwest Acupuncture College Page 14

21 Management; administrative. Accreditation. Financial. Workforce Members of the College s workforce are not considered business associates. Treatment exception When the College discloses PHI to health care providers under independent employment contract for the purpose of providing treatment or supervising treatment to the patient, those health care providers are not considered business associates. III. PROPOSED AGREEMENTS WITH BUSINESS ASSOCIATES Proposed business associate agreements College employees must forward to the privacy officer all proposed agreements between the College and an entity or individual, including an outside contractor, in which the College will provide access to PHI. If an employee is uncertain whether the outside contractor will have access to PHI, he or she is instructed to forward the agreement to the privacy officer for review. Review of proposed agreements To determine whether a business associate agreement is required, the privacy officer will review each agreement between the College and an outside contractor if the contractor will use and disclose PHI pursuant to the agreement. IV. REQUIRED ELEMENTS OF A BUSINESS ASSOCIATE AGREEMENT A business associate contract must be in writing and must include provisions that: 1. Establish the permitted and required uses and disclosures of PHI by the business associate. 2. Prohibit other uses and disclosures by the business associate, except that the contract may permit the business associate to use and disclose PHI for the proper management and administration of its business and to provide data aggregation services for the College. 3. Require appropriate safeguards to be implemented by the business associate to prevent inappropriate use or disclosure. 4. Require the business associate to report to the College any inappropriate use or disclosure of PHI of which it becomes aware. 5. Ensure that agents and subcontractors of the business associate who receive PHI from the College also agree to the same restrictions and requirements with regard to use and disclosure of the PHI. 6. Require the business associate to comply with HIPAA s requirement to allow individuals to review and copy their PHI. 7. Require the business associate to make available information that is required to provide an accounting of disclosures. 8. Require the business associate to make its internal practices, books, and records concerning PHI available to HHS. Southwest Acupuncture College Page 15

22 9. Provide for the return or destruction (or if not feasible, the continued protection) of all PHI by the business associate at the termination of the contract. 10. Authorize the College to terminate the contract if the business associate violates a material term of the contract. Optional provisions in the business associate contract In addition to the required elements listed above, the business associate contract may also contain additional elements. 1. The business associate contract may permit the business associate to use the PHI it receives from the College for the proper management and administration of the business associate or to carry out the legal responsibilities of the business associate if: a. The disclosure is required by law; or b. The business associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will be held confidentially and used or further disclosed only as required by law for the purpose for which it was disclosed to that person, and the person notifies the business associate of any instances of which the person is aware in which the confidentiality of the PHI has been breached. 2. The business associate contract may permit the business associate to provide data aggregation services to the College. V. PRIVACY VIOLATIONS COMMITTED BY A BUSINESS ASSOCIATE Employee s duty to notify If an employee knows or has reason to believe that a business associate of the College is inappropriately using or disclosing PHI, whether the PHI was received by the College or not, the employee is required to notify the College s privacy officer immediately regarding the suspected violation. Review of alleged violations Upon receiving notice of an alleged or actual violation of a business associate agreement from any source, including notice obtained through patient complaints and employee reports, the privacy officer will initiate a review of the conduct or activities at issue. Investigation and resolution of violations If the privacy officer determines that the complaint, report or other form of notice contains substantial and credible evidence of violations by a business associate, the privacy officer will commence a formal investigation into the conduct or activities of the business associate. 1. If the investigation reveals that a business associate has violated its agreement with the College, the privacy officer shall notify legal counsel immediately. 2. If the privacy officer and/or legal counsel determine that the business associate has committed a material breach or violation of its obligations under the business associate agreement, the privacy officer, with the assistance of legal counsel, must take reasonable steps to remedy the breach or terminate the contract of a business associate when feasible. If termination of the contract is not feasible, the Southwest Acupuncture College Page 16

23 College must report the problem to the Department of Health and Human Services ( HHS ). MARKETING POLICY All College marketing communications must comply with the HIPAA privacy rules specific requirements as well as any applicable state law or regulations. PURPOSE The purpose of this policy is to assist employees of the College in complying fully with all of the complex HIPAA rules governing marketing practices that involve PHI, while allowing employees the flexibility to best serve both the College and its patients. I. DEFINITION OF MARKETING Marketing defined Marketing is a communication about a product or service that encourages recipients of the communication to buy or use the product or service. Marketing specifically includes an arrangement between the College and a third party whereby the College discloses PHI, in exchange for direct or indirect remuneration, for the third party or its affiliate to make a communication about its own product or service that encourages recipients of the communication to buy or use that product or service. Exceptions to the definition of marketing Marketing does not include communications made by the College: 1. For the patient s treatment; 2. For case management or care coordination for the patient, or to recommend alternative treatments, therapies, health care providers, or settings of care; or 3. To describe a health-related product or service (or payment for such product or service) that is provided by the College, or included in a plan of benefits of a covered entity, including communications about the entities participating in a health care provider or health plan network, replacement of, or enhancement to, a health plan, and health-related products or services available only to a health plan enrollee that add value to, but are not part of, a plan of benefits. Examples of exceptions Examples of communications that should not be considered marketing include, but are not limited to, communications regarding the following: 1. Refill reminders; 2. Certain therapeutic substitution recommendations; 3. Information regarding insurance coverage and formularies; 4. Certain disease management activities; 5. Notifying patients about the College s network participation; and 6. General health information, such as communications that explain how to lower cholesterol or enroll in wellness programs. Southwest Acupuncture College Page 17

24 II. USE AND DISCLOSURE OF PHI FOR MARKETING PURPOSES General rule A College employee may use or disclose a patient s PHI for marketing purposes only if the College has obtained a valid, written authorization from the patient. Exceptions to the general rule A College employee may use and disclose PHI without an authorization to make a marketing communication to a patient, if the communication: 1. Occurs in a face-to-face encounter with the patient; or 2. Concerns promotional gifts of nominal value provided by the College (e.g., calendars, pens, and other general, inexpensive promotional merchandise. Format requirements The authorization must conform in all respects with the requirements set forth in the College s Authorizations Policy. In addition, if the marketing involves direct or indirect remuneration to the College from a third party, the authorization must state that such remuneration is involved. Business associates and other third parties 1. The College s products or services. The College may engage a business associate to conduct marketing activities on its behalf. For example, the College could hire a marketing firm to use PHI to send refill reminders to patients. The marketing firm would be acting as a business associate of the College, because it would be using the PHI on behalf of the College. For more information on business associates, see the College s Business Associates Policy. 2. The third party s products or services. However, the College may not sell or disclose PHI to a third party to help the third party market its own products or services without a signed authorization from the patient. That is, marketing occurs where an entity other than the College (including a business associate of the College) is promoting its own products using PHI it has received from, and for which it has paid, the College. REQUESTING ADDITIONAL PRIVACY POLICY It is the College s policy to evaluate all patient requests for additional restrictions on the use and disclosure of their PHI on a case-by-case basis in compliance with the procedures set forth herein. The College will accommodate a patient s reasonable request to receive communications from the College by alternative means or at alternative locations, if the patient specifies the alternative means or location. PURPOSE The purpose of this policy is to explain: (1) when a patient has a right to request that the College restrict the use or disclosure of his or her PHI, (2) when a patient has a right to request that the College send communications of PHI by alternative means or at alternative locations, and (3) the relevant procedures the College must follow to handle these requests. Southwest Acupuncture College Page 18