State Attorney General HIPAA HITECH Enforcement

My health law colleague, David Harlow, covers the news today on the first HIPAA enforcement action taken by a state attorney general under the new HITECH provision of American Recovery and Reinvestment Act of 2009 (ARRA).

David's post, HIPAA enforcement by state attorney general: The shape of things to come, provides a good summary of the announcement by the Connecticut Attorney General. More information via the Connecticut Attorney General press release.

The lawsuit filed by the Connecticut Attorney General Richard Blumenthal (coincidentally brother of David Blumenthal, National Coordinator of Health Information Technology) alleges that a health insurer, Health Net of Connecticut, Inc., failed to promptly notify the AG and other officials of a missing portable computer disk drive that contained unencrypted protected health information, Social Security numbers and bank accounts for approximately 446,000 individuals. The lawsuit also named UnitedHealth Group Inc. and Oxford Health Plans, LLC who acquired ownership of Health Net of Connecticut. The action also seeks a court order against Health Net to encrypt all information held on electronic devices.

Since the early days of HIPAA implementation and compliance there has largely been a lack of real enforcement efforts. The new provisions under HITECH allowing state attorney generals to file HIPAA enforcement actions on behalf of the public bring a new era of enforcement against health care providers who are unfortunate to have a health data breach and fail to properly respond to such breach in a timely manner.

David offers some good advice and takeaway points to health care providers and others who regularly handle health information. It is not enough to have policies and procedures in place but to regularly monitor whether they are being followed. Today's health data is liquid and it can flow in many directions. Providers need to understand where and how data is stored, used and transferred.

HISPC Reports on State Health Information Law, Business Practice and Policy

The Office of the National Coordinator for Health Information Technology (ONC) has made available a compendium of reports which detail variations in state health information law, business practices and policy related to privacy and security of health information and the electronic exchange of health information.

The reports were developed in 2009 as a part of the ongoing efforts of the Health Information Security and Privacy Collaboration (HISPC) that started in 2006 when I had the the opportunity to work on the initial round of HISPC work as it related to West Virginia. The efforts by HISPC was to take a national look (at a state level) on the privacy and security challenges faced by the variation of state laws, policies and practices.

The reports will be a great resource for those who regularly look at state health information legal issues. Following are the summaries of the five reports along with links to the various tables/appendices:

• Report on State Medical Record Access Laws This report analyzes state laws that are intended to require health care providers (specifically, medical doctors and hospitals) to afford individuals access to their own health information and to identify potential barriers to the electronic exchange of health information. Specific state law provisions examined: scope of medical records to which patients are afforded access, format of information furnished, deadlines for responding to requests, fees for furnishing copies, record retention laws and access to records of minors.
• Report on State Law Requirements for Patient Permission to Disclose Health Information In Phase I of the HISPC project a majority of participants reported significant variation in the business practices and policies surrounding the need for and process of obtaining patient permission to use and disclose personal health information for a variety of purposes, including for treatment. This report furthers the initial work of this project by collating and analyzing state laws that govern the disclosure of identifiable health information for treatment purposes to identify commonalities and differences.
• Releasing Clinical Laboratory Test Results: Report on Survey of State Laws For this report, state statutes and regulations were analyzed to determine to whom clinical laboratories may release test results. This report focused on clinical laboratory and hospital licensing laws (that contain standards for hospital laboratories). It also examined general state medical record access laws to determine whether they provided an avenue for patients to access their clinical laboratory results directly.
• Report on State Prescribing Laws: Implications for e-Prescribing This report identifies and analyzes the impact and variation of state laws related to e-prescribing. The report addresses state laws related to the e-prescribing of controlled and non-controlled substances as well as topics such as record keeping and content requirements, out-of-state prescriptions, and generic substitution laws.
• Perspectives on Patient Matching: Approaches, Findings, and Challenges This report analyzes various approaches to matching patients to their health information in the context of electronic health information exchange. Current and potential methods for matching patients to their health records are discussed, challenges to performing patient matching such as scalability and ease of use are analyzed, and the types of information some HIOs use to match patients to their health records is described.

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).

Modern Day Hatfield-McCoy: Google Health and Microsoft HealthVault

The Hatfields and McCoys, a metaphor for a modern day high-tech industry rivalry centered on personal health records (PHRs) involving Google Health, Microsoft HealthVault and other PHR vendors. An image that a West Virginia health care lawyer can really appreciate.

Thanks to a tweet by @2healthguru for pointing out the CNET article, Microsoft, Google in healthy competition. The article provides a good overview of the developing PHR movement and some insight into the future. However, I'm a bit concerned by the accuracy of the article when I see two of the individuals mentioned in the article (Matthew Holt and Dave deBronkart) tweeting (here and here) that they weren't really interviewed for the article.

Later this week I will be in D.C.along with others testifying at the Hearing on Personal Health Records before the National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Privacy, Confidentiality and Security . The Subcommittee is looking at the future of the PHR marketplace and consumer-facing health information technology.

The story of the Hatfield-McCoy feud is woven into the fabric of southern West Virginia lore along the Tug River and well known by all West Virginians. Above is a photo of the West Virginia Hatfield clan around 1897, led by Devil Anse Hatfield, second from the left. For more history and photos check out the West Virginia Division of Culture and History.

Note: If you are into off-road vehicle trails, come visit West Virginia and check out the modern day version -- the Hatfield-McCoy Trails.

Virginia Department of Health Professions Breach: Extortion Demand Regarding 8M Patient Records and 35M Prescriptions

Information Week is covering a story involving an extortion letter sent last week to the Virginia Department of Health Professions seeking $10M to return more than 8M patient records and 35M prescriptions allegedly stolen from the Virginia Department of Health Professions.

The extortion demand was posted on WikiLeaks. The WikiLeaks website states:

May 3, 2009
Summary

On Thursday, April 30, the secure site for the Virginia Prescription Monitoring Program (PMP) was replaced with a $US10M ransom demand:

"I have your shit! In *my* possession, right now, are 8,257,378 patient records and a total of 35,548,087 prescriptions. Also, I made an encrypted backup and deleted the original. Unfortunately for Virginia, their backups seem to have gone missing, too. Uhoh :(For $10 million, I will gladly send along the password."

The site, https://www.pmp.dhp.virginia.gov/pmpwebcenter/login.aspx appears to have been entirely disabled and is presently unavailable.
The linked file provides the full ransom message.
The PMP is used by pharmacists and others to discover prescription drug abuse.
The PMP declined to comment, although when contacted, appeared to be aware of the issue, instantly referring inquiries to the director of the DHP, who is presently unavailable.

The Virginia Department of Health Professions website indicates that they are "currently experiencing technical difficulties which affet computerand email systems."

Sandra Whitely Ryals, Director of Virginia Department of Health Professionals, responded to the inquiry by Information Week stating that "a criminal investigation is under way by federal and state authorities."

The Washington Post Security Fix blog is also covering this story. Follow more news on this story via Google News.


UPDATE (5/5/09): At the bottom of his follow up post, John Chilmark asks the question: "Now the question is, under HIPAA, does the VDHP have to send out breach notifications to all consumers whose records have been compromised?

Here is my quick assessment. The HIPAA privacy rule (pre-ARRA HITECH) does not contain provisions that require a covered entity to notify individuals impacted by an alleged breach. However, when I have assisted clients with these types of data breach situations in the past I typically discuss with the client whether it is good practice to provide notification. The HIPAA privacy rule provisions do contain a requirement that a covered entity should mitigate potential harm to patients/individuals when there is a violation of the privacy rule. My interpretation is that this might, under certain circumstances, include providing notice to such individuals whose data has been compromised. Also, a question that factors into the equation is whether or not the Virginia Department of Health Professsions qualifies as either a covered entity or business associate under the HIPAA privacy rule. Handling these situations are very fact specific and depend upon a number of factors.

The new federal breach notification requirements contained in the HITECH section of the American Recovery and Reinvestment Act (ARRA) do not apply because the provisions do not go into effect until 30 days after the Department of Health and Human Services (HHS) publishes the interim final data breach notification regulations which has not yet occurred. The new federal breach notification law will be implemented in conjunction with the Federal Trade Commission's (FTC) proposed health breach notification rule that will apply to PHRs, PHR related vendors and other third party providers. The proposed rule is currently out for comment.

The regulations are currently in the works and HHS has now issued initial guidance on what data is classified as unsecured protected health information (not secured by technology that renders it "unusable, unreadable or indecipherable"). See the April 27, 2009 guidance for more on what this means. The guidance outlines the types of technologies that, if used, create a safe harbor for HIPAA privacy covered entities adn business associates to avoid having to provide notice in a situation where there has been a breach.

Also, the VDHP will likely have to assess the Virginia Data Breach Act (state-by-state survey of state breach laws by the National Conference of State Legislatures) to see whether notification or other action is required under state law.Over 40 states now have distinct state laws governing breach notification that extend to and cover everything from traditional personal information (name, social security number, etc.) to health related information. I've not dealt nor reviewed the Virginia Act but suspect a strong likelihood that notification will be required.

UPDATE (5/6/09): The Roanoke Times provides an update on the status of the pending investigation with comments from Governor Tim Kaine. The article states:

Gov. Tim Kaine said today that a hacker’s reported access to patient prescription records from a state database was “an intentional criminal act against the commonwealth by somebody who was trying to harm others” . . .

The FBI and the Virginia State Police are investigating the matter. Kaine said he could not discuss the probe.

“Right now our goal is to make sure that the investigation and criminal process works so that the person who is responsible is caught and prosecuted . . . and that we protect people whose data has been compromised,” Kaine said this morning.

The article also indicates that under Virginia law notification is required and that Virginia's breach notification law requires, like many state laws, that notice must be provided "without unreasonable delay."

The article also indicates that Virginia law requires notification of individuals whose personal information may have been accessed due to a computer security breach. The law states that notification must be provided “without unreasonable delay.”

FTC Proposed Health Breach Notification Rule for PHRs and Electronic Health Information

Yesterday, April 16, 2009, the Federal Trade Commission released its proposed Health Breach Notification Rule for Vendors of Personal Health Records (PHRs) and Electronic Health Information.

The official title of the proposed rule is: 16. C.F.R. Part 318: Notice of Proposed Rulemaking and Request for Public Comments Concerning Proposed Health Breach Notification Rule, Pursuant to the American Recovery and Reinvestment Act of 2009.

The FTC is seeking written comments electronically or in paper form. The comments must be submitted by June 1, 2009 and will be placed on the public record and made accessible at the FTC website at: http://www.ftc.gov/os/publiccomments.shtm.

The FTC's press release states:

The Federal Trade Commission today announced that it has approved a Federal Register notice seeking public comment on a proposed rule that would require entities to notify consumers when the security of their electronic health information is breached.

The American Recovery and Reinvestment Act of 2009 (the Recovery Act) includes provisions to advance the use of health information technology and, at the same time, strengthen privacy and security protections for health information. Among other things, the Recovery Act recognizes that there are new types of Web-based entities that collect or handle consumers’ sensitive health information. Some of these entities offer personal health records, which consumers can use as an electronic, individually controlled repository for their medical information. Others provide online applications through which consumers can track and manage different kinds of information in their personal health records. For example, consumers can connect a device such as a pedometer to their computers and upload miles traveled, heart rate, and other data into their personal health records. These innovations have the potential to provide numerous benefits for consumers, which can only be realized if they have confidence that the security and confidentiality of their health information will be maintained.

To address these issues, the Recovery Act requires the Department of Health and Human Services to conduct a study and report, in consultation with the FTC, on potential privacy, security, and breach notification requirements for vendors of personal health records and related entities. This study and report must be completed by February 2010. In the interim, the Act requires the Commission to issue a temporary rule requiring these entities to notify consumers if the security of their health information is breached. The proposed rule the Commission is announcing today is the first step in implementing this requirement.

In keeping with the Recovery Act, the proposed rule requires vendors of personal health records and related entities to provide notice to consumers following a breach. The proposed rule also stipulates that if a service provider to one of these entities experiences a breach, it must notify the entity, which in turn must notify consumers of the breach. The proposed rule contains additional requirements governing the standard for what triggers the notice, as well as the timing, method, and content of notice. It also requires entities covered by the proposed rule to notify the FTC of any breaches. The FTC can then post information about the breaches on its Web site, and notify the Secretary of Health and Human Services.

More information over at info.rmatics blog who appear to have done a quick summary of the proposed rule. I have only had a chance to quickly scan the proposed rule but will add addition comments once I have a chance to read the entire proposed regulations. Comments and thoughts of others are welcomed - please post your comments.