OCR Request for Information: HIPAA Privacy Rule Accounting of Disclosures under HITECH

Today the Office for Civil Rights (OCR), Department of Health and Human Services issued a Request for Information titled HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act (75 Fed Reg 23214 May 3, 2010). More information at the OCR website.


The Request for Information by OCR seeks comments from health consumers and health care providers/organizations. OCR seeks information on the following areas:

    * Understanding the interests of individuals (health consumers) with respect to learning of such disclosures; and
    * The administrative burden on covered entities (health care providers/organizations) and business associates of accounting for such disclosures.

The Request for Information states that Section 13405(c) of the Health Information Technology for Economic and Clinical Health (HITECH) Act expands an individual’s right under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to receive an accounting of disclosures of protected health information made by HIPAA covered entities and their business associates. In particular, section 13405(c) of the HITECH Act requires that the HIPAA Privacy Rule be amended to require covered entities to account for disclosures of protected health information to carry out treatment, payment, and health care operations if such disclosures are through an electronic health record.


The Request for Information requests specific comments on the following nine questions:

1. What are the benefits to the individual of an accounting of disclosures, particularly of disclosures made for treatment, payment, and health care operations purposes?

2. Are individuals aware of their current right to receive an accounting of disclosures? On what do you base this assessment?

3. If you are a covered entity, how do you make clear to individuals their right to receive an accounting of disclosures? How many requests for an accounting have you received from individuals?

4. For individuals that have received an accounting of disclosures, did the accounting provide the individual with the information he or she was seeking? Are you aware of how individuals use this information once obtained?

5. With respect to treatment, payment, and health care operations disclosures, 45 CFR 170.210(e) currently provides the standard that an electronic health record system record the date, time, patient identification, user identification, and a description of the disclosure. In response to its interim final rule, the Office of the National Coordinator for Health Information Technology received comments on this standard and the corresponding certification criterion suggesting that the standard also include to whom a disclosure was made (i.e., recipient) and the reason or purpose for the disclosure. Should an accounting for treatment, payment, and health care operations disclosures include these or other elements and, if so, why? How important is it to individuals to know the specific purpose of a disclosure— i.e., would it be sufficient to describe the purpose generally (e.g., for ‘‘for treatment,’’ ‘‘for payment,’’ or ‘‘for health care operations purposes’’), or is more detail necessary for the accounting to be of value? To what extent are individuals familiar with the different activities that may constitute ‘‘health care operations?’’ On what do you base this assessment?

6. For existing electronic health record systems:
(a) Is the system able to distinguish between ‘‘uses’’ and ‘‘disclosures’’ as those terms are defined under the HIPAA Privacy Rule? Note that the term ‘‘disclosure’’ includes the sharing of information between a hospital and physicians who are on the hospital’s medical staff but who are not members of its workforce.
(b) If the system is limited to only recording access to information without regard to whether it is a use or disclosure, such as certain audit logs, what information is recorded? How long is such information retained? What would be the burden to retain the information for three years?
(c) If the system is able to distinguish between uses and disclosures of information, what data elements are automatically collected by the system for disclosures (i.e., collected without requiring any additional manual input by the person making the disclosure)? What information, if any, is manually entered by the person making the disclosure?
(d) If the system is able to distinguish between uses and disclosures of information, does it record a description of disclosures in a standardized manner (for example, does the system offer or require a user to select from a limited list of types of disclosures)? If yes, is such a feature being utilized and what are its benefits and drawbacks?
(e) Is there a single, centralized electronic health record system? Or is it a decentralized system (e.g., different
departments maintain different electronic health record systems and an accounting of disclosures for treatment,
payment, and health care operations would need to be tracked for each system)?
(f) Does the system automatically generate an accounting for disclosures under the current HIPAA Privacy Rule (i.e., does the system account for disclosures other than to carry out treatment, payment, and health care
operations)?
i. If yes, what would be the additional burden to also account for disclosures to carry out treatment, payment, and health care operations? Would there be additional hardware requirements (e.g., to store such accounting information)? Would such an accounting feature impact system performance?
ii. If not, is there a different automated system for accounting for disclosures, and does it interface with the electronic health record system?

7. The HITECH Act provides that a covered entity that has acquired an electronic health record after January 1, 2009 must comply with the new accounting requirement beginning January 1, 2011 (or anytime after that date when it acquires an electronic health record), unless we extend this compliance deadline to no later than 2013. Will covered entities be able to begin accounting for disclosures through an electronic health record to carry out treatment, payment, and health care operations by January 1, 2011? If not, how much time would it take vendors of electronic health record systems to design and implement such a feature? Once such a feature is available, how much time would it take for a covered entity to install an updated electronic health record system with this feature?

8. What is the feasibility of an electronic health record module that is exclusively dedicated to accounting for disclosures (both disclosures that must be tracked for the purpose of accounting under the current HIPAA Privacy Rule and disclosures to carry out treatment, payment, and health care operations)? Would such a module work with covered entities that maintain decentralized electronic health record systems?

9. Is there any other information that would be helpful to the Department regarding accounting for disclosures
through an electronic health record to carry out treatment, payment, and health care operations?

Written comments to OCR must be submitted on or before May 18, 2010.

OCR Update on Issuance of HIPAA HITECH Rulemaking

Update from Office for Civil Rights (OCR) on issuance of the Notice of Proposed Rulemaking (NPRM) implementing changes to HIPAA under the Health Information Technology for Economic and Clinical Health Act (HITECH). Health care organizations and health lawyers have been anxiously awaiting rules implementing and interpreting the changes because the effective date for many of the HITECH requirements was February 17, 2010. Of particular interest has been whether or not health care organizations are required to amend business associate agreement.

The notice seems to indicate that the the date for compliance and enforcement may be delayed since it states that the NPRM "will provide specific information regarding the expected date of compliance and enforcement." However, covered entities and business associates need to weigh the risks of not complying with the new requirements while waiting for further clarification from OCR.

The notice states:

OCR will implement important privacy and security provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act through notice and comment rulemaking, as required by the Administrative Procedure Act. These provisions include: business associate liability; new limitations on the sale of protected health information, marketing, and fundraising communications; and stronger individual rights to access electronic medical records and restrict the disclosure of certain information. OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions. Although the effective date (February 17, 2010) for many of these HITECH Act provisions has passed, the NPRM and the final rule that follows will provide specific information regarding the expected date of compliance and enforcement of these new requirements.

However, interim final rules implementing HITECH Act provisions in two areas have already been issued and are currently in effect: enforcement and breach notification. New civil money penalty amounts apply to HIPAA Privacy and Security Rule violations occurring after February 17, 2009. Covered entities and business associates must comply now with breach notification obligations for breaches that are discovered on or after September 23, 2009. OCR announced previously that it would use its enforcement discretion not to impose fiscal sanctions with regard to breaches discovered before February 22, 2010. Since that date has passed, OCR will enforce the Breach Notification Interim Final Rule, including with the possible imposition of sanctions, as it does with the HIPAA Privacy and Security Rule requirements.

OCR Designates HIPAA Regional Office Privacy Advisors

The Acting Director and Principal Deputy Director for the Office for Civil Rights, Robinsue Frohboese, has designated Office for Civil Rights Regional Managers in each of the HHS Regional Offices to serve as the Regional Office Privacy Advisors. On July 27, 2009, Secretary Sebelius authorized the Director of the Office for Civil Rights to carry out the designation required under the Health Information Technology for Economic and Clinical Health (HITECH) Act (Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA).

The designation of these Regional Office Privacy Advisors was mandated by the ARRA-HITECH provisions under Section 13403(a). The Regional Office Privacy Advisors will offer guidance and education to covered entities, business associates, and individuals on their rights and responsibilities related to the HIPAA Privacy and Security Rules

The names, addresses, and contact information for each of the Regional Managers are listed together with a list of the States for which each Regional Manager has responsibility are listed below:

Region I - Boston (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont)
Peter Chan, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
Government Center
J.F. Kennedy Federal Building - Room 1875
Boston, MA 02203
Voice phone(617)565-1340
FAX (617)565-3809
TDD (617)565-1343

Region II - New York (New Jersey, New York, Puerto Rico, Virgin Islands)
Michael Carter, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
Jacob Javits Federal Building
26 Federal Plaza - Suite 3312
New York, NY 10278
Voice Phone (212)264-3313
FAX (212)264-3039
TDD (212)264-2355

Region III - Philadelphia (Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia)
Paul Cushing, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
150 S. Independence Mall West
Suite 372, Public Ledger Building
Philadelphia, PA 19106-9111
Main Line (215)861-4441
Hotline (800) 368-1019
FAX (215)861-4431
TDD (215)861-4440

Region IV - Atlanta (Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee)
Roosevelt Freeman, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
Atlanta Federal Center, Suite 3B70
61 Forsyth Street, S.W.
Atlanta, GA 30303-8909
Voice Phone (404)562-7886
FAX (404)562-7881
TDD (404)331-2867

Region V - Chicago (Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin)
Valerie Morgan-Alston, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
233 N. Michigan Ave., Suite 240
Chicago, IL 60601
Voice Phone (312)886-2359
FAX (312)886-1807
TDD (312)353-5693

Region VI - Dallas (Arkansas, Louisiana, New Mexico, Oklahoma, Texas)
Ralph Rouse, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
1301 Young Street, Suite 1169
Dallas, TX 75202
Voice Phone (214)767-4056
FAX (214)767-0432
TDD (214)767-8940

Region VII - Kansas City (Iowa, Kansas, Missouri, Nebraska)
Frank Campbell, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
601 East 12th Street - Room 248
Kansas City, MO 64106
Voice Phone (816)426-7277
FAX (816)426-3686
TDD (816)426-7065

Region VIII - Denver (Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming)
Velveta Howell, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
1961 Stout Street -- Room 1426 FOB
Denver, CO 80294-3538
Voice Phone (303)844-2024
FAX (303)844-2025
TDD (303)844-3439

Region IX - San Francisco (American Samoa, Arizona, California, Guam, Hawaii, Nevada)
Michael Kruley, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
90 7^th Street, Suite 4-100
San Francisco, CA 94103
Voice Phone (415)437-8310
FAX (415)437-8329
TDD (415)437-8311

Region X - Seattle(Alaska, Idaho, Oregon, Washington)
Linda Yuu Connor, Regional Manager
Office for Civil Rights
U.S. Department of Health and Human Services
2201 Sixth Avenue - M/S: RX-11
Seattle, WA 98121-1831
Voice Phone (206)615-2290
FAX (206)615-2297
TDD (206)615-2296

HIPAA Security Rule Enforcement Delegated to OCR

Today HHS Secretary Kathleen Sebelius announced that enforcement of the Security Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) will be delegated to the Office for Civil Rights (OCR).

The official delegation occurred on July 27, 2009. More information about the transition of authority for the administration and enforcement of the Security Rule can be found in the OCR press release. The official Delegation of Authority by the Office of the Secretary has been issued and will appear in the August 4, 2009 Federal Register.

Prior to today, administration and enforcement of the HIPAA Security Rule has been the responsibility of the Centers for Medicare & Medicaid Services (CMS).

HITECH Act Breach Notification Guidance: What Renders PHI Unusable, Unreadable or Indecipherable For Purposes of Breach Notification?

On April 17, 2009, the U.S. Department of Health & Human Services (HHS) issued guidance on the technology requirements to render protected health information (PHI) "unusable, unreadable or indecipherable to unauthorized individuals, as required by the Health Information Technology for Economic and Clinical Health Act (HITECH) which is a part of the American Recovery and Reinvestment Act of 2009 (ARRA).

The April 27, 2009 Federal Register (74 FR 19006),contains the official copy of the regulation, Guidance Specifying the Technologies and Methodologies That Render Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals for Purposes of the Breach Notification Requirements Under Section 13402 of Title XIII (Health Information Technology for Economic and Clinical Health Act) of the American Recovery and Reinvestment Act of 2009; Request for Information

The guidance is effective as of April 17, 2009. However, the guidance will apply to breaches 30 days after publication of the interim final regulations.

HHS's press release on the guidance states:

The guidance issued today provides steps entities can take to secure personal health information and establishes the trigger for when entities must notify that patient data has been compromised. This guidance is related to “breach notification” regulations, which will be issued by HHS and the Federal Trade Commission respectively. The HHS regulations will apply to entities covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the FTC regulation will apply to vendors of personal health records and certain others not covered by HIPAA. The Recovery Act requires that these regulations be published within 180 days of enactment.
The guidance was developed through a joint effort by the HHS Office for Civil Rights (OCR), Office of the National Coordinator for Health Information Technology (ONC), and Centers for Medicare &Medicaid Services (CMS).

The guidance also seeks public comments on the guidance as well as the breach notification provisions under FTC's new Health Breach Notification Rule and the yet to be releases HHS Breach Notification Requirements for HIPAA Covered Entities and Business Associates. Public comments must be submitted on or before May 21, 2009.