SOURCES SOUGHT
R -- Evaluation of State Privacy Regulations in Relation to the Sentinel Initiative
- Notice Date
- 7/29/2009
- Notice Type
- Sources Sought
- NAICS
- 541199
— All Other Legal Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1062261SourcesSought
- Archive Date
- 8/22/2009
- Point of Contact
- Keith Austin,
- E-Mail Address
-
keith.austin@fda.hhs.gov
(keith.austin@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. Statement of Objectives: In May 2008, the Secretary of Health and Human Services and the FDA Commissioner announced the Sentinel Initiative. The Sentinel Initiative is a long-term effort by the Agency to create a national electronic system for monitoring product safety. The Sentinel Initiative is intended to augment the Agency’s existing post-market (primarily passive) safety surveillance systems and to allow the Agency to actively gather information about the post-market safety and performance of its regulated products. As currently envisioned, the Sentinel Initiative will enable the Agency to capitalize on the capabilities of multiple, existing automated healthcare data systems (e.g. electronic health record systems, administrative claims databases, registries, or others) to augment the Agency’s current surveillance capabilities. The Sentinel Initiative will enable queries of disparate data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be included. Questions would be sent to appropriate, participating data sources, who in turn would, in accordance with existing privacy and security safeguards, evaluate their data and send results for Agency review. The Sentinel Initiative is a response to various calls for this type of effort from the Agency. In September 2005, the HHS Secretary asked the Agency to expand its current system for monitoring medical product performance and to explore the possibility of working with multiple automated healthcare data systems to augment the Agency’s current capabilities of identifying and evaluating product safety information. The Secretary recommended that the Agency explore creating a public-private collaboration as a framework for such an effort, leveraging large, automated healthcare databases. In 2006, the IOM issued a report, entitled The Future of Drug Safety—Promoting and Protecting the Health of the Public. Among other suggestions, this IOM report recommended the Agency identify ways to access other health-related databases and create a public-private partnership to support safety studies. In 2007, Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 905 of this statute calls for the HHS Secretary to develop methods to obtain access to disparate data sources and to establish an active post-market risk identification and analysis system that links and analyzes safety data from multiple sources. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also requires the Agency to work closely with partners from public, academic, and private entities. The Agency views its Sentinel Initiative as a mechanism through which some of the requirements mandated in this legislation can be carried out. The Sentinel Initiative is a long-term effort that must proceed in stages. The initial stage of the Sentinel Initiative has allowed the Agency to further refine the requirements and develop the scope. The Agency has funded 8 contracts to support this initial stage. In addition to this ongoing contractual work, there are many ongoing activities in the public and private sector that will inform the Sentinel Initiative. The Agency has hosted a series of meetings with various stakeholder groups, to include other federal agencies; data sources and environments; academics and experts; patient, consumer, and provider groups; and IT vendors. In addition, in December 2008 a public workshop was held to discuss the Sentinel Initiative with the following objectives: •To provide an update on the current status of the Sentinel Initiative and allow for comment from all stakeholders •To discuss potential governance models and their implications •To discuss approaches to ensuring continued involvement of all stakeholders as the initiative evolves As a part of the work conducted under contract with the eHealth Initiative Foundation, an analysis of legal issues related to structuring the FDA Sentinel Initiative activities was conducted. This report noted that: The use of health information for pharmacovigilance implicates state health information confidentiality laws, as well. Each participant in the Sentinel Initiative should look carefully at its state statutes and regulations to determine whether those state laws impose any additional restrictions on the conduct of the program beyond the federal law requirements discussed. Because it is beyond the scope of this report to cover the laws of all 50 states, we address typical categories of state laws that may limit use of information in the Sentinel Initiative—laws protecting particularly sensitive information such as genetic testing, mental health, and HIV/AIDS information—and use different state laws as examples of the analysis that would be applied. In addition to the work that has been done specifically to support the Sentinel Initiative, the Department of Health and Human Services, through the Office of the National Coordinator for Health IT, has been exploring state law relating to privacy that could affect electronic health information exchange generally. As part of that effort, it has commissioned a report on state disclosure laws relating to health information that is expected to be available in the fall of this year. That report will be useful in addressing the questions that are the focus of this request, and it will be expected that work done in response to this request will build on, and not duplicate, that report. The Agency would like to conduct a legal evaluation of state statutes, regulations and practices in each of the 50 states in order to determine whether data sources may participate in the Sentinel Initiative and the conditions on that participation. It is noted that Federal regulations, including the HIPAA Privacy Rule constitutes a minimum for privacy protection, so states can enact more rigorous privacy protection if desired. The Agency is seeking a thorough evaluation of state statutes and regulations to determine whether those state laws impose any additional restrictions on the use or disclosure of health information beyond the federal law requirements discussed in the legal analysis already received by the Agency and if so to set out what those additional restrictions entail. The Food and Drug Administration (FDA) is seeking to identify firms that meet the criteria as defined above with relevant experience in evaluating privacy regulations. The focus for the requirement includes, but is not limited to: Developing a report outlining state laws within each of the 50 states, relating to privacy, protection of subjects, sale of healthcare data, and other restrictions that would affect the planned approach for Sentinel System. Small Businesses are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform the task described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. If qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 5. Identification of any GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding five (5) pages in length. Phone calls will not be accepted or returned. Interested firms or individuals may submit the requested information to: keith.austin@fda.hhs.gov or US Food and Drug Administration Keith Austin 5630 Fishers Lane / HFA-500 OAGS/DAO Rm 2138 Rockville, MD 20857
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