Wednesday, April 29, 2009

Google Experimental Flu Trends for Mexico

Google Flu Trends have launched an Experimental Flu Trends for Mexico as a result of the ongoing concern over the current swine flue outbreak. The experimental model for Mexico shows estimates on possible flu activity in the various states in Mexico. Google Flu Trends uses aggregated Google search data to estimate possible flu activity in near real-time.

Additional details on how the Experimental Flu Trends for Mexico works and FAQs. More information about Google Flu Trends in my prior post.

Thanks to @rzeiger for the Twitter tip on the launch of the experimental tracker.

Friday, April 24, 2009

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.

WV Senator Rockefeller: The Health Information Technology Public Utility Act of 2009

Yesterday West Virginia Senator Jay Rockefeller introduced "The Health Information Technology Public Utility Act of 2009"(Senate Bill 890) to facilitate the nationwide adoption of electronic health records (EHRs) though an "open source" public utility model.

A copy of Senate Bill 890 is available on Thomas (GPO PDF version).  According to the press release the Act would:
  • Create a new federal Public Utility Board within the Office of the National Coordinator for Health IT to direct and oversee formation of this HIT Public Utility Model, its implementation, and its ongoing operation.
  • Implement and administer a new 21st Century Health IT Grant program for safety-net providers to cover the full cost of open source software implementation and maintenance for up to five years, with the possibility of renewal for up to five years if required benchmarks are met.
  • Facilitate ongoing communication with open source user groups to incorporate improvements and innovations from them into the core programs.
  • Ensure interoperability between these programs, including as innovations are incorporated, and develop mechanisms to integrate open source software with Medicaid and CHIP billing.
  • Create a child-specific Electronic Health Record (EHR) to be used in Medicaid, CHIP, and other federal children’s health programs.
  • Develop and integrate quality and performance measurement into open source software modules.

Tuesday, April 21, 2009

Microsoft and Mayo Clinic Collaboration: Mayo Clinic Health Manager

Today Microsoft Corporation and Mayo Clinic announced a new consumer online health service called Mayo Clinic Health Manager, build on the HealthVault platform.

The press release states that Mayo Clinic Health Manager provides individuals "a place to store medical information and receive real-time individualized health guidance and recommendations based on the clinical expertise of Mayo Clinic . . . [extending] the capabilities of traditional personal health records, using an individual's health information to generate customized recommendations on which they can act to help them better manage their health and the health of their families."

Learn more from the Media Kit or take a tour.

How does this change the current PHR landscape?

Like others who have been commenting today I see this as combining the power brand of Mayo Clinic and its guidelines with what appears to be simple PHR tools designed to allow you to record, track, monitor, etc. your health information. However, at this point it still doesn't get over the hurdle of the individual having to individually input their own data.

Will health consumers become engaged to take on this role? Can providers and payors start to feed good data into the system to lessen the burden on the consumer/patient? What role will state and federal payors play in these systems? How will we all address the issues raised by Dave deBronkart (e-patientDave) which have been the center of discussion on the health blogosphere the past couple of weeks.

More questions than answers.

UPDATE (4/23/09): Did Microsoft sign a HIPAA Business Associate Agreement as a part of the collaboration? In HIPAA lawyer jargon the real question is "whether Mircrosoft is offering a service for or on behalf of the Mayo Clinic and is receiving protected health information." Answer per Microsoft from Nei Versel's Healthcare IT Blog.

Fourth Circuit Affirms Summary Judgment Under Health Care Quality Improvement Act of 1986

Congratulations to my partners, Rick Jones and David Givens for successfully defending Charleston Area Medical Center, Inc. before the United States Court of Appeals for the Fourth Circuit in the matter of Wahi v. Charleston Area Medical Center, Inc., et al., Slip Op. No. 06-2162 (4th Cir. April 10, 2009). Rick argued the case against well known lawyer, Kenneth Starr, who represented Rakesh Wahi, M.D., the appellant in the matter.

Following is a summary and some of the significant points regarding the impact on peer review privileges.
Wahi v. Charleston Area Medical Center, Inc., et al., Slip Op. No. 06-2162 (4th Cir. April 10, 2009) is a significant decision analyzing the immunity provisions of the Health Care Quality Improvement Act of 1986 (“HCQIA”). It affirms summary judgment on various claims made by the Plaintiff, a cardiothoracic surgeon, arising from the suspension of his privileges at Charleston Area Medical Center (“CAMC”), a Charleston, West Virginia hospital. The underlying facts and procedural history span over a decade of Dr. Wahi's tenure at CAMC. Dr. Wahi was granted privileges at CAMC in 1993. For a variety of reasons, CAMC summarily suspended his privileges in 1996 and reported the suspension, as required, to the National Practitioner Data Bank ("NPDB"). Following rehabilitative efforts, Dr. Wahi was granted restricted privileges.

Subsequently, there were documented instances of Wahi practicing outside the scope of his restricted privileges, as well as charges of practicing below the standard of care. In July 1999, Dr. Wahi was again summarily suspended, and requested a hearing under the applicable provisions of the hospital’s governing documents.

Not satisfied with the hearing procedures set forth in the governing documents, Dr. Wahi retained counsel to negotiate with the hospital over the hearing process. He objected to the hearing examiners, procedures, and ultimately sought the intervention of a state circuit court before the hearing process even began. Following the state court's refusal to intervene, Dr. Wahi ceased efforts to move forward with the hearing process and, some five years later, filed suit in the United States District Court for the Southern District of West Virginia alleging anti-trust monopolization and conspiracy, breach of contract, civil rights conspiracy, defamation and breach of contract. Following limited discovery on the application of immunity under HCQIA1, CAMC moved for summary judgment. Judge Goodwin granted CAMC's motion as to all counts finding that Dr. Wahi failed to rebut the statutory presumption of immunity. Dr. Wahi appealed.

The Fourth Circuit found that Dr. Wahi abandoned any appellate claim as to three of the four prongs under the HCQIA immunity standards and focused its immunity analysis solely on the issue of whether CAMC’s failure to actually set and hold a hearing deprived the hospital of its legally presumed immunity.

The Fourth Circuit affirmed summary judgment, finding the hospital was immune for its actions under the HCQIA despite the fact that a hearing was never actually scheduled or conducted. CAMC’s notification to Dr. Wahi of the charges, the hospital’s many attempts to provide a hearing, and Dr. Wahi’s non-cooperation in the hearing process led the court to conclude that CAMC’s process, when considered in its totality, satisfied the minimum standard of reasonableness required under HCQIA. The Court found that Dr. Wahi’s evidence was simply insufficient to overcome the statutory presumption of immunity under HCQIA, and affirmed the district court's ruling.

The Court also affirmed the District Court’s refusal to grant injunctive relief, finding Wahi did not prove CAMC committed any wrong; that CAMC was not a “state actor” for purposes of § 1983 claims; that he failed to amend his complaint to include a defamation claim, making it non reviewable on appeal; and, that because the hospital bylaws did not form a contract under state law, Dr. Wahi could not allege breach of contract for any violation of the bylaws. A final argument rejected by the Court was Dr. Wahi’s claim that CAMC breached confidentiality required by 45 C.F.R. § 60.13 by disclosures to the press, finding the NPDB “does not prevent the entity who reported NPDB from disclosing the mere fact that a report was filed.”

The Wahi opinion has significance for hospitals and others involved in peer review matters:
  • HCQIA provides a means of minimizing and limiting discovery to issues related to the availability of immunity to a hospital. HCQIA provides a vehicle through which a hospital may obtain summary disposition of cases without running the risks associated with a jury trial.
  • For a hospital to avail itself of HCQIA immunity, there need not be precise compliance with all the elements of one’s governing documents, but the hospital may show from a totality of the circumstances that its handling of the matter was objectively reasonable.
  • HCQIA’s “safe harbor” provisions should be read expansively and not narrowly construed.
  • The reasonableness of a hospital’s actions is not a subjective determination, and neither good nor bad motives should be considered; rather, the court should look at the objective, overall reasonableness of the hospital’s actions, even if it is later determined that the facts were different or the standard of care was actually met.
  • A hospital should use care in properly documenting the information upon which it acts and the manner of notifying the physician of the charges and, above all else, make sure the physician is fully advised of the charges and given the opportunity to explain or rebut any charges against him. Proper documentation of all the steps required for HCQIA is crucial.
Rick and David would like to recognize fellow partner, Nate Tawney, and associate, Justin Jack who also worked on defending the matter and assisted in the preparation of this summary.

The Economist: Health 2.0 How far can interactive digital medicine go?

The Economist looks in on Health 2.0 in the article, Health 2.0: How far can interactive digital medicine go?

Highlights for me:
  • Quote by Neil Seeman who thinks Health 2.0 is important "because it reinvents how we identify opinion leaders and exploit disruptive innovation."
  • Steve Case, founder of America Online, who likens the current state of digital medicine to the late 1970s hwen Apple ushered in the age of personal computing.
  • Concluding remarks taht Health 2.0 might not be revolution but instead reformation and recognition that the shift towards patient empowerment is "unstoppable."

Sunday, April 19, 2009

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.

Friday, April 17, 2009

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:

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.

Tuesday, April 14, 2009

Neurology Today: When Moving Records and Practices, Know Your Legal Obligations.

I was interviewed for an article appearing in the March 19 2009, edition of Neurology Today. The article, When Moving Records and Practices, Know Your Legal Obligations (pdf version), was written by Elizabeth Stump and discusses the current legal requirements and recommendations regarding medical record retention, release of information, storage and requirements for notification of patients when a physician leaves a practice.

Sunday, April 12, 2009

2009 Legislative Changes to WV Certificate of Need Law

On April 9, 2009, the West Virginia Legislature sent Senate Bill 321 to Governor Manchin for signature (see strikethru/underline Committee Substitute version). Senate Bill 321 makes substantive changes to the current certificate of need law in West Virginia overseen by the West Virginia Health Care Authority.

The certificate of need law requires health care providers, including hospital, physicians, long term care facilities, hospice providers, home health agencies and other health care providers to first seek approval prior to expanding health services, incurring capital expenditures above a particular threshold, purchasing certain medical equipment and developing or acquiring new health facilities or services.

Below is a summary of the major changes to the law that will go into effect 90 days from passage on April 3, 2009:
  • The bill raises the capital expenditure threshold and major medical equipment threshold from $2,000,000 to $2,700,000.
  • Eliminates lithotripsy from certificate of review.
  • Amends the fee structure of the Health Care Authority for certificate of need reviews.
  • Provides that in specified instances nonhealth-related projects are not subject to certificate of need review.
  • Provides that in specified instances certain ambulatory health care facilities are not subject to certificate of review.
  • Eliminates from certificate of review acquisition of any health care facility outside of West Virginia by a West Virginia health care facility.

Friday, April 10, 2009

WV Music Law Blog: DIY Music Mogul

A welcome to another West Virginia lawyer blogger, Kevin Levine, who is blogging now at DIY Music Mogul. His blog is dedicated to assisting entrepreneurial musical artists and songwriters with timely and relevant information about music law and business.

Kevin is an entertainment and intellectual property lawyer with Kay Casto & Chaney, PLLC in Charleston, West Virginia. He is also the Executive Creative Director of Blue 11 Music Publishing, LLC, an independent music publishing company.

Today I met Kevin (via phone) as a fellow participant in the Create WV effort and learned about his blog.

Welcome to the West Virginia blogging community and great to see a music law focused blog eminating from West Virginia which has an incredibly rich music history. A history from past to present with events like Vandalia Gathering, Mountain Stage and Capitol Music Hall and people like Brad Paisley, Kathy Matea, Johnny Johnson, Little Jimmy and many others.

Thursday, April 09, 2009

Obama Signs Executive Order Officially Creating White House Office of Health Reform

Yesterday, April 8, 2009, President Obama signed an executive order formally creating a new White House Office of Health Reform.

The Washington Post provide additional information, including the complete text of the Executive Order and that former Clinton administration official, Nancy-Ann DeParle (White House bio) will oversee the office.

The full text of the Executive Order:


By the authority vested in me as President by the Constitution and the laws of the United States of America, and in the interest of providing all Americans access to affordable and high-quality health care, it is hereby ordered as follows:

Section 1. Policy.

Reforming the health care system is a key goal of my Administration. The health care system suffers from serious and pervasive problems; access to health care is constrained by high and rising costs; and the quality of care is not consistent and must be improved, in order to improve the health of our citizens and our economic security.

Sec. 2. Establishment.

(a) There is established a White House Office of Health Reform (Health Reform Office) within the Executive Office of the President that will provide leadership to the executive branch in establishing policies, priorities, and objectives for the Federal Government's comprehensive effort to improve access to health care, the quality of such care, and the sustainability of the health care system.
(b) The Secretary of Health and Human Services, to the extent permitted by law, shall establish within the Department of Health and Human Services (HHS) an Office of Health Reform, which shall coordinate closely with the White House Office of Health Reform.

Sec. 3. Functions. The principal functions of the Health Reform Office, to the extent permitted by law, are to:

(a) provide leadership for and to coordinate the development of the Administration's policy agenda across executive departments and agencies concerning the provision of high-quality, affordable, and accessible health care and to slow the growth of health costs; this shall include coordinating policy development with the Domestic Policy Council, National Economic Council, Council of Economic Advisers, Office of Management and Budget, HHS, Office of Personnel Management, and such other executive departments and agencies as the Director of the Health Reform Office may deem appropriate;
(b) work with executive departments and agencies to ensure that Federal Government policy decisions and programs are consistent with the President's stated goals with respect to health reform;
(c) integrate the President's policy agenda concerning health reform across the Federal Government;
(d) coordinate public outreach activities conducted by executive departments and agencies designed to gather input from the public, from demonstration and pilot projects, and from public-private partnerships on the problems and priorities for policy measures designed to meet the President's goals for improvement of the health care system;
(e) bring to the President's attention concerns, ideas, and policy options for strengthening, increasing the efficiency, and improving the quality of the health care system;
(f) work with State, local, and community policymakers and public officials to expand coverage, improve quality and efficiency, and slow the growth of health costs;
(g) develop and implement strategic initiatives under the President's agenda to strengthen the public agencies and private organizations that can improve the performance of the health care system;
(h) work with the Congress and executive departments and agencies to eliminate unnecessary legislative, regulatory, and other bureaucratic barriers that impede effective delivery of efficient and high-quality health care;
(i) monitor implementation of the President's agenda on health reform; and
(j) help ensure that policymakers across the executive branch work toward the President's health care agenda.

Sec. 4. Administration. (a) The Health Reform Office may work with established or ad hoc committees, task forces, or interagency groups.

(b) The Health Reform Office shall have a staff headed by the Director of the Health Reform Office (Director). The Health Reform Office shall have such staff and other assistance as may be necessary to carry out the provisions of this order.
(c) As requested by the Director, each executive department and agency shall designate a liaison to work with the Health Reform Office on improving access to health care, the quality of health care, and the sustainability of the health care system.
(d) All executive departments and agencies shall cooperate with the Health Reform Office and provide such information, support, and assistance to the Health Reform Office as it may request, to the extent permitted by law.

Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) authority granted by law to a department, agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

April 8, 2009.