Legal Health Information Exchange - Legal issues relating to electronic health information exchange

In a Press Release posted today, February 2nd, ONC announced that providers and public health agencies in Minnesota and Rhode Island began this month exchanging health information using specifications developed by the Direct Project, which is described as an "open government" initiative that calls on cooperative efforts by organizations in the health care and information technology sectors. The ONC Press Release notes that other Direct Project pilot programs will also be launched soon in New York, Connecticut, Tennessee, Texas, Oklahoma and California. The story is also covered today by the New York Times in Steve Lohr's article "U.S. Tries Open-Source Model for Health Data Systems".

The ONC Press Release notes that Direct Project is intended to give health care providers early access to an easy-to-use, internet-based tool that can replace mail and fax transmissions of patient data with secure and efficient electronic health information exchange.  It was designed as part of President Obama’s ‘open government’ initiative to drive rapid innovation, and last year is said to have brought together some 200 participants from more than 60 companies and other organizations. Volunteers worked together to assemble consensus standards that support secure exchange of basic clinical information and public health data. Now, pilot testing of information exchange based on Direct Project specifications is being carried out this year with the aim toward formal adoption of the standards by 2012.

ONC states that information exchange supported by Direct Project specifications address core needs, including standardized exchange of laboratory results; physician-to-physician transfers of summary patient records; transmission of data from physicians to hospitals for patient admission; transmission of hospital discharge data back to physicians; and transmission of information to public health agencies. The Press Release also notes

[t]hat in addition to representing most-needed information transfers for clinicians and hospitals, these information exchange capabilities will also support providers in meeting 'meaningful use' objectives established last year by HHS, and will thus support providers in qualifying for Medicare and Medicaid incentive payments in their use of electronic health records.

If you would like more information about Direct Project, or have questions such as:

• How does direct exchange fit into the big picture?
• How is direct exchange different than HIE initiatives?
• Does direct exchange support or supplant State HIE initiatives?
• What is the security model for Direct Project?
• Who issues Digital Certificates for users?
• What are the limitations of the Direct Project model?

Then, check out the following links for excellent information:

• Direct Project Overview
• Direct Project Implementation Group
• Direct Project FAQs
• Direct Project Pilots

In response to mounting privacy concerns, the federal Office of Personnel Management (OPM) may delay the proposed November 15^th launch date of its Health Claims Data Warehouse. In early October, the OPM’s notice in the Federal Register announced that the “Warehouse” would be built to streamline operations of the Federal Employee Health Benefit Program, the National Pre-Existing Condition Insurance Program, and the Multi-State Option Plan- three programs that were included in this year’s Health Reform legislation. The OPM said that the “Warehouse” would collect, manage, and analyze health services data through direct data feeds from each program. The electronic records compiled would include individuals’ personal information such as Social Security Number, date of birth, and employment, as well as information about their healthcare coverage, procedures, and diagnoses. In its announcement, the OPM also noted that it would share this information for law enforcement purposes, judicial and administrative proceedings, and third-party health research and analysis.

In response to the OPM’s announcement, 16 organizations, including The Center for Democracy and Technology (CDT) and the ACLU, released a letter to the OPM citing concerns about the lack of available details about the new database. In particular, the letter pressed the OPM for details about the database’s security and privacy controls, and urged the OPM not to establish the “Warehouse” until the public had a fair chance to review its plans. In response, the OPM has promised to release further details after reviewing public comments, which can be submitted to the OPM up until November 15^th. Whether this will delay the launch of the “Warehouse” has not yet been confirmed. However, when the OPM does release their plans, it will be important to ask if such a large government database is necessary, and if it violates the public’s privacy expectations.

This post was prepared with assistance from Melody Hsiou. Melody holds a Master from Public Health from Columbia University, and anticipates completing her Juris Doctorate with a Health Law Concentration from Seton Hall Law School in 2013.