Learning: Privacy and Security Monitoring, Audits and Investigations

On November 13, 2007, I will be speaking at a Lorman Eduational Services seminar to be held in Charleston, West Virginia. The seminar topic is "Health Care Information Privacy and Security Monitoring, Audits and Investigations: How to avoid an investigation and what you should expect if the state or federal officials call". You can register online here.

Also speaking at the seminar will be (read full bios):

• Terri Barrett, the assistant chief privacy officer at the West Virginia Health Care Authority in Charleston

• Mike Harmon, compliance officer for the West Virginia Public Employees Insurance Agency who oversees HIPAA compliance for PEIA and the Department of Administration

• Jack Shaffer, CIO for the Community Health Network of West Virginia who has experience in all aspects of technology, including systems development, enterprise application integration, networking, telecommunications, data center operations, database administration, disaster recovery, security and mobile computing.

Below is a copy of the seminar agenda:

9:00 am – 10:30 am	Legal Overview of HIPAA Privacy and Security Enforcement
	Robert L. Coffield, Esq.
	HIPAA Refresher on Enforcement Rules and Penalties OCR Privacy Investigation Statistics Best Practices on Conducting Internal Investigations Responding to OCR/CMS Investigation
10:30 am – 10:45 am	Break
10:45 am – 11:30 am	Preparing for an Audit
	Michael T. Harmon, CIPP/G
	Auditing vs. Monitoring Other Governmental Auditors – e.g., OIG, Legislature Elements of the OIG Audit of Piedmont Hospital in Atlanta New Kennedy/Leahy Legislation and Changes to Current Practice Privacy and Security Accreditation
11:30 am – 12:30 pm	Lunch (On Your Own)
12:30 pm – 2:30 pm	Technologies and Procedures for HIPAA Compliance
	Jack L. Shaffer Jr.
	Acceptable Use Policies and Enforcement Protecting PHI With Encryption Technologies Auditing and Monitoring Tools
2:30 pm – 2:45 pm	Break
2:45 pm – 3:45 pm	The Role of the Privacy Officer
	Terrisita Barrett, CIPP
	The Changing Privacy and Security Landscape Role and Responsibilities: Past, Present and Future Challenges Affecting the Privacy Officer Role
3:45 pm – 4:30 pm	Panel Discussion, and Questions and Answers
	Terrisita Barrett, CIPP, Robert L. Coffield, Esq.,
	Michael T. Harmon, CIPP/G, and Jack L. Shaffer Jr.

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).

Providence Health & Services Agrees To $100,000 Voluntary Settlement of Potential HIPAA Violation

The U.S. Department of Health and Human Services (HHS) issued a press release last Thursday that it had entered into a Resolution Agreement with Seattle-based Providence Heath & ServicesHealth Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security rules. The agreement calls for Providence to pay a voluntary settlement of $100,000 and implement a detailed corrective action plan to ensure against future theft or loss of electronic patient health information (ePHI).

The incidents giving rise to the agreement involved two Providence entities, Providence Home and Community Services and Providence Hospice and Home Care. On or about December 30, 2005, data contained on several computer backup disks and tapes was stolen from the unattended car of a Providence employee. In addition to the theft of disks and tapes, several laptop computers were stolen from Providence employees on September 29, 2005, December 7, 2005, February 27, 2006, and March 3, 2006. The laptops, disks and tapes involved in those thefts contained the unencrypted records of more than 386,000 patients of Providence.

Under the terms of the Resolution Agreement, Providence agrees to pay $100,000 by check or electronic funds to HHS. Providence also agrees to enter into and abide by the terms of the Corrective Action Plan that is incorporated into the agreement. The Corrective Action Plan is effective for three years and requires that Providence submit copies of its written policies and procedures to HHS for approval. The Corrective Action Plan outlines nine categories of minimum content required in the policies and procedures. Specifically, the Corrective Action Plan requires that Providence to:

• Conduct a risk assessment of potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI when it is created, received, maintained, used or transmitted off-site;
• Implement a risk management plan that incorporates security measures sufficient to reduce the risks and vulnerabilities identified by the risk assessment to a reasonable and appropriate level; and
• Implement several physical and technical safeguards, including encryption, to ensure the protection of ePHI whenever it is stored or transported off-site by any portable device or electronic media.

The Corrective Action Plan also requires Providence train and monitor its workforce so that all employees are familiar with the policies and procedures. Providence is also required to submit to HHS both a one-time Implementation Report and Annual Reports for three years detailing its compliance to the policies and procedures under the Resolution Agreement.

Initially, HHS officials received more than 30 complaints about the stolen tapes and disks after Providence, pursuant to state notification laws, informed patients of theft. Providence also reported the stolen media to HHS. Providence faced a pending class action lawsuit alleging that the health system failed to safeguard the data as required by HIPAA and violated Oregon’s Unfair Trade Practices Act. The proposed class action was dismissed in November, 2007. The incident was also investigated by the Oregon Attorney General’s Office resulting in an Assurance of Voluntary Compliance Agreement requiring Providence to provide credit monitoring services, credit restoration services, implement security program enhancements and pay $95,764 into the Consumer Protection and Education Revolving Account.

Providence settlement and corrective action plan sends a signal that OCR and CMS are taking a stronger position against privacy and security incidents. The settlement should prompt providers who are required to comply with HIPAA to reexamine their privacy and security policies, procedures, employee training protocols and ongoing monitoring of compliance.

MD Net Guide Article: Are Physician Blogs in a Legal and Ethical Twilight Zone?

Last month I had the opportunity to collaborate with Fard Johnmar of Envision Solutions on an article for MD Net Guide, "Social Media Notebook: Are Physician Blogs in a Legal and Ethical Twilight Zone?" The article looks at the recent incident involving Dr. Lindeman, who blogged under the pseudonym "Flea," and the risks associated with physician blogging.

I shared some legal tips that physician bloggers should consider when blogging, including:

• Anonymous blogging does not guarantee your privacy
• Consider informing your employer about your blog
• Follow your HIPAA training
• Post a legal disclaimer
• Be cautious about giving advice to patients

Check out the current issue of MD Net Guide to read the complete article. Also, the complete article, "Social Media Notebook: Are Physician Blogs in a Legal and Ethical Twilight Zone?" can be accessed via the web (registration required).

University of California Settles Potential HIPAA Privacy and Security Violations with OCR for $865,500

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced that the University of California at Los Angeles Health System which includes UCLA Ronald Reagan Medical Center, UCLA Santa Monica Medical Center, and Orthopedic Hospital, Resnick Neuropsychiatric Hospital, and the Faculty Practice Group of UCLA (UCLAHS) has agreed to settle potential violations under the HIPAA Privacy and Security Rules for $865,500. Read the OCR press release.

The settlement highlights that hospitals, physicians, and other covered entities must understand the importance of monitoring the level of access workforce members have to medical and health information. Covered entities must have policies and procedures in place and educate workforce members about only accessing records for necessary and permissible purposes. This settlement resulted from an investigation by OCR after certain celebrity/VIP patients at the UCLA facilities complained that hospital staff, including unauthorized physicians, had inappropriately accessed their health and medical information.

UCLAHS agreed to a Corrective Action Plan for a period of three years under the terms of the Resolution Agreement. The Corrective Action Plan requires UCLAHS to review/update its current HIPAA policies and procedures, conduct follow up workforce training, monitor compliance and submit a monitoring plan, and submit an implementation report and annual reports to OCR. of can be found attached to the Resolution Agreement.

The Resolution Agreement described the events that occurred that lead to the settlement as follows:

On June 5, 2009 and June 30, 2009, HHS began investigations of two separate complaints alleging that the Covered Entity was in violation of the Privacy and/or Security Rules. The investigations indicated that the following conduct occurred (“Covered Conduct”):

(i) During the period from August 31, 2005 to November 16, 2005, numerous Covered Entity workforce members repeatedly and without a permissible reason examined the electronic protected health information of Covered Entity patients, and during the period from January 31, 2008 to February 2, 2008, numerous Covered Entity workforce members repeatedly and without a permissible reason examined the electronic protected health information of a Covered Entity patient.

(ii) During the period 2005-2008, a workforce member of Covered Entity employed in the office of the Director of Nursing repeatedly and without a permissible reason examined the electronic protected health information of many patients.

(iii) During the period 2005-2008, Covered Entity did not provide and/or did not document the provision of necessary and appropriate Privacy and/or Security Rule training for all members of its workforce to carry out their function within the Covered Entity.

(iv) During the period 2005-2008, Covered Entity failed to apply appropriate sanctions and/or document sanctions on workforce members who impermissibly examined electronic protected health information.

(v) During the period from 2005-2009, Covered Entity failed to implement security measures sufficient to reduce the risks of impermissible access to electronic protected health information by unauthorized users to a reasonable and appropriate level.

 More information and background can be found in the iHealthBeat article, UCLA Health System Agrees to Pay $865K over Privacy Breaches, including a link to a statement on the settlement issued by UCLH Health System.

SAMHSA and ONC: FAQs on Substance Abuse Confidentiality Regulations for HIEs

The Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of the National Coordinator for Health Information Technology (ONC) announced last week the release of FAQs for Applying the Substance Abuse Confidentiality Regulations to Health Information Exchanges (HIEs).

Cover letter regarding the FAQs by Pamela S. Hyde, the Administrator of SAMHSA, and David Blumenthal, National Coordinator for ONC. The letter describes that the the Substance Abuse Confidentiality Regulations under 42 CFR Part 2 were enacted years ago (circa 1975). Due to the age of the regulations SAMHSA and ONC created the FAQs to provide guidance and understanding of the scope of these regulations in the context of today's move toward an electronic health information system.

The FAQs outline the general requirements under 42 CFR Part 2, provide guidance on its application to HIEs, and identify methods for including substance abuse related health information into HIEs that is consistent with the Federal statute.

As a follow-up to the release of the FAQs, SAMHSA and ONC will convene a meeting of concerned or interested parties from both the Behavioral Health and Information Technology (BH-IT) communities on August 4, 2010. The meeting will be an opportunity for SAMHSA and ONC to receive questions and comments on the FAQs.

The FAQs for Applying the Substance Abuse Confidentiality Regulations to Health Information Exchanges (HIEs) provide information on the following 37 questions:

1. Does the federal law that protects the confidentiality of alcohol and drug abuse patient records allow information about patients with substance use disorders to be included in electronic health information exchange systems?
2. What types of providers are covered programs under 42 CFR Part 2 (“Part 2”)?
3. What patients, and which records and information, are protected by 42 C.F.R Part 2?
4. For the purposes of the applicability of 42 CFR Part 2, does it matter how HIOs are structured?
5. Does 42 CFR Part 2 permit the disclosure of information without a patient’s consent for the purposes of treatment, payment, or health care operations?
6. Under Part 2, can a Qualified Service Organization Agreement (QSOA) be used to facilitate communication between a Part 2 program and an HIO?
7. May information protected by Part 2 be made available to an HIO for electronic exchange?
8. If Part 2 information has been disclosed to the HIO, either pursuant to a Part 2- compliant consent form authorizing such disclosure or under a QSOA, may the HIO then make that Part 2 information available to HIO-affiliated members?
9. How do different HIO patient choice models regarding whether general clinical health information may be disclosed to or through an HIO (e.g., no consent, opt in or opt out) affect the requirements of 42 CFR Part 2?
10. If an HIO is holding or storing Part 2 patient data through a QSOA, can the HIO redisclose the data coming from the Part 2 program to a third party without patient consent?
11. What are the required elements of a patient consent under Part 2?
12. What must a Part 2 program do to notify the HIO, or any other recipient of Part 2 protected information, that it may not redisclose Part 2 information without patient consent?
13. Can a single consent form be used to authorize the disclosure of Part 2 information to an HIO, as well as authorize the redisclosure of that information to other identified parties, such as HIO affiliated members?
14. Does Part 2 allow the use of multiple-party consent forms?
15. Does Part 2 require the use of original signed consents?
16. Under Part 2, may an HIO release demographic information about Part 2 patients without patient consent?
17. Under Part 2, can an HIO reveal that a patient had an encounter at a mixed use facility (or “general medical” facility – see FAQ #2) as long as the HIO does not reveal that the patient was in the mixed use facility’s Part 2 program? A mixed use facility can be defined as a service provider organization that provides substance abuse treatment services as well as other health services such as primary care, dental care, mental health services, social services, etc.
18. Under Part 2, can an HIO use a consent form that provides for disclosure to “HIO members” and refers to the HIO’s website for a list of those members?
19. Can an HIO use a consent form under Part 2 to allow for the disclosure of information to future HIO affiliated health care providers?
20. Can an HIO use a consent form under Part 2 to allow for the disclosure of information to health care providers who are providing on-call coverage for HIO affiliated health care providers or with whom those affiliated providers consult?
21. Can a Part 2 patient consent be used to enable multiple disclosures?
22. Can a Part 2 program or HIO use a consent form that has no specific expiration date but rather states that disclosure is permitted until consent is revoked by the patient?
23. Is “treatment” a sufficient description of the intended purpose of a disclosure on a Part 2 consent?
24. Under Part 2, can any health care provider make the determination that a medical emergency exists, or must a Part 2 provider make that determination?
25. May a computer system be used to automatically determine whether a medical emergency exists and whether a disclosure of Part 2 data can be made without the patient’s consent?
26. If a medical emergency exists, can the entire Part 2 record be released?
27. For documentation purposes, if a medical emergency is present, would it be permissible under Part 2 to have treating providers simply check a drop down box signifying the existence of such a medical emergency?
28. Under Part 2, may an HIO system make clinical decision support functions (such as showing a patient’s medications to clinicians when they write prescriptions, automatically ordering medications, and/or alerting clinicians about potential drug interactions) available to HIO affiliated health care providers in a medical emergency?
29. Does the Part 2 definition of medical emergency also include mental health emergencies?
30. When the HIO keeps an electronic record of a medical emergency, does that fully meet Part 2’s requirement to document disclosures made in a medical emergencies in the patient’s record?
31. If an HIO’s electronic system makes a disclosure in a medical emergency, would documenting the name of the discloser as “electronically disclosed through the system administered by HIO” meet Part 2’s requirement that the name of the person who made the disclosure be documented in the patient’s record?
32. If an HIO’s electronic system sends Part 2 data in a medical emergency to a printer or fax machine in the emergency room, can “the printer in the emergency department” meet Part 2’s requirement to document in the patient’s record the name of the person to whom the disclosure was made?
33. Once Part 2 information is disclosed in a medical emergency, can that information be redisclosed without obtaining patient consent?
34. If a patient has previously refused to consent to the release of his/her Part 2 record to a particular HIO affiliated health care provider, and then the patient is brought to that provider in a bona fide medical emergency situation, can that provider gain access through the HIO to the information without the patient’s consent under Part 2?
35. Can an HIO disclose data for Disease Management purposes under Part 2 without patient consent?
36. Under Part 2, would an HIO be permitted to disclose to an HIO affiliated payer the data of several patients held by the HIO, which may include Part 2 data, in order for the payer to target where interventions could be made with particular patients to improve care and management of disease?
37. If an HIO affiliated health care provider wishes to gain access to a minor’s Part 2 record held by the HIO, may the HIO or provider obtain only the consent of a parent or guardian, or must the minor’s consent also be obtained?

Microsoft HealthVault: You put your right HIPAA in . . .

In a post today, Sean Nolan, Chief Architect of Microsoft Health Solutions and blogger at Family Health Guy explains Microsoft's position regarding whether Microsoft HealthVault is required to comply with the privacy standards under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The blog post, "You put your right HIPAA in . . ." provides some background on the process that Microsoft has gone through to look at the question of whether they are directly required to comply with HIPAA as a "covered entity" or whether the must enter into "business associate agreement"with other covered entities. Although they don't reach a final definitive conclusion Microsoft does state that they are now prepared to sign a business associate agreement with any covered entity who concludes that it is important as a part of their compliance and responsibility under HIPAA.

The post by also includes a link to the standard Microsoft HealthVault Business Associate Agreement.

The conclusion reached by Microsoft seems like a practical one to this health care lawyer. Anyone who deals with health information has a responsibility to assess whether or not they are a covered entity under HIPAA. They further have a responsibility to be a part of the conversation with those other person that they deal with who are covered entities as to whether a business associate agreement must be in place. However, the final decision of whether a business associate agreement is required must be made by the covered entity who is responsible for complying with the privacy provisions.

The determination of whether a particular party is a business associate under HIPAA is one that largely depends on the unique facts of the relationship that they have with a covered entity under HIPAA. There is not a blanket determination of whether someone is or is not a business associate for purposes of HIPAA compliance. The questions that must be asked to assess whether a business associate relationship exists under 160.103 and 164.502 are:

1. Does the person/party "perform or assist" in the performance of a "function or activity" involving the use or dislcosure of individually identifiable health information" OR
2. Does the person/party provide certain "professional services to or for the covered entity" involving the disclosure of individually identifiable health information (as these terms are futher defined under the regulations).

As stated in the post there is still unclear areas as a result of the ARRA HITECH privacy provisions that will still need to be sorted out as we move forward. However, the important issue is to continue to move forward.

HIPAA Privacy Rule Accounting of Disclosures under HITECH

Today's Federal Register includes the Office of Civil Rights (OCR) Notice of Proposed Rulemaking (NPRM) modifying the HIPAA Privacy Rule's Accounting of Disclosure requirements for protected health information. OCR was required to make these modifications to the HIPAA Privacy Rule to implement the requirements under the Health Information Technology for Economic and Clinical Health Act (HITECH) section of the ARRA.

HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act, Office for Civil Rights, Notice of Proposed Rulemaking (76 FR 31426, May 31, 2011)

The regulations greatly expand the responsibility for health care covered entities and business associates to document and track the use and disclosure of health information held in an electronic health record (EHR). Health care providers and business associates should plan to thoroughly review these new regulations to understand the impact on their existing policies and procedures.

The regulations outline new procedures for accounting of disclosures of health information held in an electronic health record and disclosed for treatment, payment, and health care operations (as defined under HIPAA). The accounting period under the proposed regulations is three years. The proposed regulations focus on two rights for individuals -- a right to an accounting of disclosure and a "new" right to an access report. The new access report does not distinguish between a use (think internal use by a health care provider) and disclosure (providing the information to a third party). Instead the new right to an access report focuses on whether someone "accessed" the information in the EHR.

Previously under HIPAA, uses and disclosures for treatment, payment, and health care operations (commonly referred to as "TPO") were exempt from the accounting of disclosures requirements. The requirement for accounting for some limited uses and disclosures has always been a part of the HIPAA Privacy Rule.

The rule proposes separate compliance dates for the changes to the accounting of disclosures requirements (180 days after the effective date of the final rule - 240 days after publication of the final rule) and for the right to receive an access report (beginning January 1, 2013, for any EHR system acquired after January 1, 2009 and January 1, 2014, for any EHR system acquired on or before January 1, 2009).

My initial comments above are based upon a quick review of the proposed regulations. Official comments on the NPRM must be submitted on or before August 1, 2011.

New HHS HIPAA Privacy Compliance and Enforcement Data

DHHS and the Office for Civil Rights (OCR) have added new enforcement statistics and data to the OCR HIPAA Privacy and Compliance and Enforcement site. Previously, I've posted about the statistics.

OCR added new information broken down by the following topics:

• Charts showing state-specific case investigation results (West Virginia shows (see the graphic above): 71% resolved after intake and review; 18% corrective action taken; 11% no violation)
• Calendar-year enforcement results graphs and charts
• Calendar-year graphs showing the number of complaints received
• Yearly variation in the top 5 types of issues resolved through corrective action

The statistics show that the number of complaints made to OCR continue to increase -- from 6,534 complaints in 2004 to 8,132 complaints in 2007.

Also, the statistics show that the top 5 types of complaints requiring corrective action have remained fairly consistent - except in 2007 "notice" jumps into the top 5.

I would be interested to hear others thoughts on the compliance statistics.

HITECH Final Regulations Update: Coming Soon!

Susan McAndrew, deputy director for health information privacy at the Office for Civil Rights (OCR) indicated this week that various final regulations modifying the HIPAA privacy and security rules required by the Health Information Technology for Economic and Clinical Health Act (HITECH) will be issued soon. Health lawyers have been waiting on these regulations to better understand the full impact of the HITECH changes to HIPAA, including whether the "harm standard" will remain a part of the Interim Final Rule on breach notification.

According to a Health Information Security News article, McAndrew made this announcement this week while speaking at the 2011 NIST HIPAA Conference, Safeguarding Health Information: Building Assurance through HIPAA Security, held in Washington.

The article also indicated that a separate NPRM will be issued announcing the approach OCR plans to take regarding the accounting for disclosure modifications under the HITECH Act. The HITECH Act modified the traditional rule regarding those types of uses and disclosures that must be accounted for by health care providers and covered entities. Under the traditional rule -- health care providers did not have to provide an accounting of disclosure for uses and disclosures for treatment, payment, and health care operations. However, the modification by the HITECH Act now requires health care providers who utilize an electronic health record system (EHR)to provide, upon request, an accounting of disclosure of all uses and disclosures including those for treatment, payment, and health care operations which occurred within the last three year period. Of further interest will be how the NPRM suggests how business associates who obtain PHI from health care providers must also track and maintain a list of uses and disclosures for accounting of disclosure requests.

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.

AHLA Teleconference: HIPAA Privacy Fundamentals

Next month I will be co-presenting on an American Health Lawyer Association Teleconference on the topic of HIPAA Privacy Regulation Fundamentals - An Introductory Course.

The teleconference is scheduled for May 13, 2009, 1:00 - 2:30 pm EST. My co-presenter is Rebecca L. Williams of Davis Wright Tremaine LLP and the moderator will be Phyllis Granade of Adorn & Yoss.

This teleconference is geared toward a gaining a basic understanding of HIPAA privacy law for health lawyers (think, HIPAA 101). We will also be discussing the impact of the changes unde rthe HITECH Act of 2009. Although geared toward health lawyers this teleconference would also be valuable for health care professionals and others in the industry interested in learning more about HIPAA.

You can find out more about the teleconference and how to register via the AHLA website.

New HIPAA Privacy Compliance and Enforcement Website

Yesterday I received an email via the OCR-Privacy listserv announcing the launch of a new HHS web site on HIPAA Privacy Compliance and Enforcement.

I haven't had time to check out the new website but plan to in the coming days. While scanning the website I found the "Enforcement Highlights" and "Case Examples" section very interesting. In the meantime, here is the press release issued in the email by HHS.

To coincide with the fourth anniversary of the enforcement of the HIPAA Privacy Rule, the Department of Health and Human Services (HHS) announced today the launch of an enhanced Web site that will make it easier for consumers, health care providers and others to get information about how the Department enforces health information privacy rights and standards. In launching the website, Winston Wilkinson, the Director of the HHS Office for Civil Rights, noted: "HHS has obtained significant change in the privacy practices of covered entities through its enforcement program. Corrective actions obtained by HHS from these entities have resulted in change that is systemic and affects all the individuals they serve."

The Health Information Privacy Web site provides comprehensive information about the Privacy Rule, which creates important federal rights and requirements to protect the privacy of personal health information. The enhanced Web site, http://www.hhs.gov/ocr/privacy/enforcement provides information for consumers, health care providers, health plans and others in the health care industry about HHS’s compliance and enforcement efforts. The new information describes HHS activities in enforcing the Privacy Rule, the results of those enforcement activities, and statistics showing which types of complaints are received most frequently and the types of entities most often required to take corrective as a result of consumer complaints. The other information on the Web site covers consumers’ rights to access their health information and significantly control how their personal health information is used and disclosed, as well as guidance about how to submit complaints about possible violations of the law and extensive guidance for entities who must comply with the rule.

HHS issued the patient privacy protections pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The first and only comprehensive federal privacy standards to protect patients' medical records and other health information provided to health plans, doctors, hospitals and other health care providers took effect on April 14, 2003. Developed by HHS, these standards provide patients with access to their medical records and more control over how their personal health information is used and disclosed. The regulation covers health plans, health care clearinghouses, and those health care providers who conduct certain financial and administrative transactions (e.g., enrollment, billing and eligibility verification) electronically. HHS has conducted extensive outreach and provided guidance and technical assistance to providers and businesses to help them to implement the new privacy protections. These materials are available at http://www.hhs.gov/ocr/hipaa.

Tweet By Hospital Employee: What information is considered PHI?

Interesting Tweet HIPAA Breach story coming out of Mississippi involving Governor Haley Barbour. The incident involved a response to Governor Barbour's tweet by a University Medical Center employee.

Ves Dimov, M.D. at Clinical Cases and Images Blog posts about the story - Single tweet by hospital employee to Mississippi Governor allegedly violates HIPAA, forces her to resign.

The incident will provide a good case study for health privacy lawyers who regularly consider the question of what information is and is not protected health information (PHI) under 45 CFR 160.103. PHI is defined under HIPAA as:

The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information "protected health information (PHI)."

“Individually identifiable health information” is information, including demographic data, that relates to:

• the individual’s past, present or future physical or mental health or condition,
• the provision of health care to the individual, or
• the past, present, or future payment for the provision of health care to the individual,

and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual. Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number).

Thanks for the tip @RLBates and @EdBennett.

Lorman Medical Records Law Seminar: March 18, 2010

On March 18, 2010 I will be speaking on Medical Records Law at a seminar in Charleston, West Virginia. The seminar is sponsored by Lorman Educational Services. Joining me for the day long seminar will be three very knowledgeable health care colleagues:

• Michael T. Harmon, MPA, CIPP/G, Compliance Specialist for the West Virginia Mutual Insurance Company, a Medical Professional Liability Insurance Company
• Sallie H. Milam, J.D., CIPP/G, Executive Director of the West Virginia Health Information Network and Chief Privacy Officer for the West Virginia State Government
• James W. Thomas, Esq., Manager of the Charleston, West Virginia Business Law Department of Jackson Kelly PLLC whose practice focuses primarily upon health care matters of a business, regulatory and operational nature
  

Additional information about the seminar and how to register can be found at Lorman Educational Services. Following is the full seminar agenda:

8:30 am – 9:00 am			Registration
9:00 am – 9:15 am			Overview
9:15 am – 10:30 am			HIPAA Compliance: Reality and Perspective
			— Michael T. Harmon, MPA, CIPP/G
			Overview Enforcement Complaints Case Examples Summary of HITECH Changes
10:30 am – 10:45 am			Break
10:45 am – 12:00 pm			HITECH Financial Incentives for Implementation of HIT
			— James W. Thomas, Esq.
			Qualifying an Electronic Health Record System Available Financial Incentives
12:00 pm – 1:00 pm			Lunch (On Your Own)
1:00 pm – 2:00 pm			Health Information Exchange in West Virginia: Impact on Patient Records
			— Sallie H. Milam, J.D., CIPP/G
2:00 pm – 2:15 pm			Break
2:15 pm – 3:30 pm			Consumer Driven Health Care: HITECH, Health 2.0, Social Media and Personal Health Records
			— Robert L. Coffield, Esq.
			HITECH Breach Notification Requirements Impact of Health 2.0 and Social Media Technology on the Future of Health Care Development and Adoption of Personal Health Records Discuss the Legal Implications of Emerging Technology
3:30 pm – 4:30 pm			Panel Discussion
			— Robert L. Coffield, Esq., Michael T. Harmon, MPA, CIPP/G, Sallie H. Milam, J.D., CIPP/G and James W. Thomas, Esq.

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.

ONCHIT Issues Nationwide Privacy and Security Framework for Electronic Exchange of Health Information

Today the Office of the National Coordinator for Health Information Technology (ONCHIT) issued The Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information. The summary states that the framework creates a set of consistent principles to:

". . .address the privacy and security challenges related to electronic health information exchange through a network for all persons, regardless of the legal framework that may apply to a particular organization. The goal of this effort is to establish a policy framework for electronic health information exchange that can help guide the Nation's adoption of health information technologies and help improve the availability of health information and health care quality. The principles have been designed to establish the roles of individuals and the responsibilities of those who hold and exchange electronic individually identifiable health information through a network."

Along with the Nationwide Privacy and Security Framework the Department of Health and Human Services (HHS) has issued The Health IT Privacy and Security Toolkit. The Toolkit includes new HIPAA Privacy Rule guidance documents developed by the ONCHIT and the Office for Civil Rights (OCR) to help facilitate the electronic exchange of health information.

Of particular interest to many interested in PHRs will be the OCR's guidance on Personal Health Records and the HIPAA Privacy Rule and the draft Draft Model Personal Health Record (PHR) Privacy Notice & Facts-At-A-Glance (the "Leavitt Label").

The Toolkit provides information and guidance focused around these key areas:

• Individual Access Principle - Individuals should be provided with a simple and timely means to access and obtain their individually identifiable health information in a readable form and format.
• Correction Principle - Individuals should be provided with a timely means to dispute the accuracy or integrity of their individually identifiable health information, and to have erroneous information corrected or to have a dispute documented if their requests are denied.
• Openness and Transparency Principle - There should be openness and transparency about policies, procedures, and technologies that directly affect individuals and/or their individually identifiable health information.
• Individual Choice Principle - Individuals should be provided a reasonable opportunity and capability to make informed decisions about the collection, use, and disclosure of their individually identifiable health information.
• Collection, Use, and Disclosure Limitation Principle - Individually identifiable health information should be collected, used, and/or disclosed only to the extent necessary to accomplish a specified purpose(s) and never to discriminate inappropriately.
• Data Quality and Integrity Principle - Persons and entities should take reasonable steps to ensure that individually identifiable health information is complete, accurate, and up-to-date to the extent necessary for the person's or entity's intended purposes and has not been altered or destroyed in an unauthorized manner.
• Safeguards Principle - Individually identifiable health information should be protected with reasonable administrative, technical, and physical safeguards to ensure its confidentiality, integrity, and availability and to prevent unauthorized or inappropriate access, use, or disclosure.
• Accountability Principle - These principles should be implemented, and adherence assured, through appropriate monitoring and other means and methods should be in place to report and mitigate non-adherence and breaches.

I have only made an initial pass though the information and guidance documents. There is a lot to read and digest over the holidays. Please post in the comments your thoughts on the new federal principles and guidelines.

Recent HIPAA Enforcement Stats

for the latest on HIPAA enforcement statistics by OCR click over to Mike Cassidy's post at the Med Law Blog: HIPAA Criminal Verdict and Enforcement Statistics. The post also contains some stats on the number of matters reported to the DOJ for investigation.

The post includes a summary of United States v. Ferrer, S.D. Fla., No. 06-CR-60261-CR-Cohn, the first criminal HIPAA verdict entered in January 2007. The case involved the wrongful disclosure of individually identifiable health information and identity theft of 1,100 patients from the Cleveland Clinic which were used to fraudulently bill Medicare claims to the tune of $7M.

HIPAA: Michigan Supreme Court Examing Preemption, Confidentiality and Ex Parte Interview of Treating Physicians in Medical Liability Litigation

The AMANews reports that the Michigan Supreme Court is examining whether the Health Insurance Portability and Accountability Act of 1996 (HIPAA) preempts state law to allow a defendant physician in a medical liability case to interview the plaintiff/patient's other treating physicians.

The history and docket information on the case before the Michigan Supreme Court, Andrea L. Holman v. Mark Rasak, SCt Case Number 137993, can be found via search here. Oral arguments were held on November 3, 2009. The Michigan Supreme Court provides a background summary of the case along with links to the briefs filed by the parties, including Amicus Curiae Briefs filed by the Michigan Association for Justice, Michigan Defense Trial Counsel, Michigan Health and Hospital Association, Michigan State Medical Society and ProAssurance Casualty Company and American Physicians Assurance Corporation.

The case involves a defendant physician who sought to interview the treating physicians, but the plaintiff/patient refused to waive her confidentiality rights under HIPAA. Plaintiff signed a HIPAA Authorization releasing the medical records but refused to provide a release for "oral communications." Defendant physician then sought a protective order to permit the ex parte interviews of the treating physicians but the circuit court denied the motion.

The circuit court concluded that the HIPAA provisions relative to the protective order only pertain to documentary evidence and that HIPAA does not authorize ex parte oral interviews.

On appeal the State of Michigan Court of Appeals in Andrea L. Holman v. Mark Rasak, D.O. ruling on November 18, 2008, reversed the circuit court's order denying the defendant physician's motion for a protective order to allow him to conduct ex parte interviews with the plaintiff/patient's treating physicians. The court held that HIPAA supersedes Michigan law to the extent that its protections and requirements are more stringent than those provided by stat law. The court held that the defendants may conduct an ex parte oral interview if a qualified protective order, consistent with 45 CFR 164.512(e)(1), is first put in place.

This will be an interesting ruling to watch. Stay tuned!