Law in the Internet Society
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Establishing a Safe, Private Online Medical Database

-- By BrendanMulligan - 09 Jan 2010

In its 1999 report, To Err is Human: Building a Safer Health System, the Institute of Medicine claimed that preventable medical errors cause as many as 98,000 deaths per year in the United States and upwards of $29 billion annually in lost income, lost household production, disability, and additional health care costs. [http://en.wikipedia.org/wiki/To_Err_is_Human] According to the report, decentralization and fragmentation of the health care system are major causes of these errors. Providers lack access to complete patient data at the point of care. Medical errors only compose part of the picture. Hundreds of thousands die every year for improper medications, adverse drug reactions, infections that occur in hospitals. [http://demo.clear-health.com/dohcs2009/pt3.mp3]

People die because the lack of infrastructure. But even though banking and retailers have successfully implemented electronic records, fewer than 2% of the nation's 5,000 non-VA hospitals have what could be considered a comparable full-fledged system. [http://online.wsj.com/article/SB124104350516570503.html] We need a health care IT system founded on two characteristics: (1) universal adoption of a routine means of digitization clinical information and (2) a system robust enough to protect the sanctity of medical information.

Universality

We should—and I believe will—move to an open source base for our health IT system. Proprietary factors have long inhibited the development of a universal system (killing many people). Vendors’ commercial systems do not easily talk to other vendors' systems. Further, the stakeholders that matter, do not want to use open source software. The Healthcare Information and Management Systems Society (HIMSS) is a powerful healthcare organization exclusively focused on fostering the optimal use of information technology (IT) and management systems for the betterment of healthcare. HIMSS hosts the largest and most well-publicized health IT conferences in the country. HIMSS, though ostensibly independent, is completely dependent upon money from proprietary donors. http://vendor.himss.org/

Congressional Response

It has earmarked nearly $20 billion in stimulus funds as an incentive for hospitals to use electronic records by 2011. The most common response to this problem has been funding a nationwide health information network in which a variety of health care providers could update and access a singular database. For example, Section 937(f) of the Senate’s health care reform bill states: ‘‘[The government] shall provide for the coordination of relevant Federal health programs to build data capacity for comparative clinical effectiveness research, including the development and use of clinical registries . . . to develop and maintain a comprehensive, interoperable data network to collect, link, and analyze data on outcomes and effectiveness from multiple sources, including electronic health records.” (1683-1684 of the bill [http://www.forhealthfreedom.org/BackgroundResearchData/SenateHealthReform/SenateHealthReformBill_11-19-09.pdf.])

Potential Problems

A nationwide health information network comes with a host of issues. Much of the debate surrounding health care information centers on safeguarding data from being lost, stolen or mishandled. [http://www.huffingtonpost.com/2009/11/13/health-industry-winning-r_n_357476.html] See also, Robert A. Gerberry, Legal Ramifications of the Formation of Digital Hospitals, 14 Health Law 27, June, 2002. “Faced with stories of confidential medical records being accidentally posted on a web site, and being emailed to all members of a computer network, patients continue to fear the misuse of confidential medical information. Online providers need to protect against the electronic misappropriation of health information by complying with confidentiality laws that seek to protect patient information.” These concerns are legitimate. In a recent survey of IT professionals, seventy percent said senior management does not view privacy and data security as a priority. [http://www.ponemon.org/local/upload/fckjail/generalcontent/18/file/Electronic%20Health%20Information%20at%20Risk%20FINAL%201.pdf] Eighty percent of respondent organizations had experienced at least one incident of lost or stolen electronic health information in the past year. [http://www.ponemon.org/local/upload/fckjail/generalcontent/18/file/Electronic%20Health%20Information%20at%20Risk%20FINAL%201.pdf] Over the last few years, the personal health information of hundreds of thousands of people has been compromised because of security lapses at hospitals, insurance companies and government agencies. [http://www.nytimes.com/2009/01/18/us/politics/18health.html] However, security need not even be breached to release private health information. The dissemination of this information is governed by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) medical privacy rule. HIPAA permits patients’ personal health information to be shared among more than 600,000 organizations without patients’ consent. 45 C.F.R. § 164.506 states that with limited exceptions “a covered entity may use or disclose protected health information for treatment, payment, or health care operations as set forth in paragraph (c) of this section.” Health care operations are defined extremely broadly, leaving almost no discernible restrictions. It includes activities such as business planning, management and administration, the sale or transfer of a covered entity, fundraising, and data analysis for plan holders or other sponsors. [link].

“However, because regional health information organizations could increase circumstances under which patient data may be inappropriately accessed, some parties have argued that regional health information organizations should adopt additional procedures to help ensure that data are used only for the intended purposes.”


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