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健康信息交换增长的法律障碍——巨石还是卵石?

Legal Barriers to the Growth of Health Information Exchange-Boulders or Pebbles?

机构信息

Stanford Law School.

Stanford University School of Medicine.

出版信息

Milbank Q. 2018 Mar;96(1):110-143. doi: 10.1111/1468-0009.12313.

Abstract

UNLABELLED

Policy Points: Historically, in addition to economic and technical hurdles, state and federal health information privacy laws have been cited as a significant obstacle to expanding electronic health information exchange (HIE) in the United States. Our review finds that over the past decade, several helpful developments have ameliorated the legal barriers to HIE, although variation in states' patient consent requirements remains a challenge. Today, health care providers' complaints about legal obstacles to HIE may be better understood as reflecting concerns about the economic and competitive risks of information sharing.

CONTEXT

Although the clinical benefits of exchanging patients' health information electronically across providers have long been recognized, participation in health information exchange (HIE) has lagged behind adoption of electronic health records. Barriers erected by federal and state health information privacy law have been cited as a leading reason for the slow progress. A comprehensive assessment of these issues has not been undertaken for nearly a decade, despite a number of salient legal developments.

METHODS

Analysis of federal and state health information privacy statutes and regulations and secondary materials.

FINDINGS

Although some legal barriers to HIE persist, many have been ameliorated-in some cases, simply through improved understanding of what the law actually requires. It is now clear that the Health Insurance Portability and Accountability Act presents no obstacles to electronically sharing protected health information for treatment purposes and does not hold providers who properly disclose information liable for privacy breaches by recipients. The failure of federal efforts to establish a unique patient identifier number does slow HIE by inhibiting optimal matching of patient records, but other action to facilitate matching will be taken under the 21st Century Cures Act. The Cures Act also creates the legal architecture to begin to combat "information blocking." Varying patient consent requirements under federal and state law are the most important remaining legal barrier to HIE progress. However, federal rules relating to disclosure of substance-abuse treatment information were recently liberalized, and development of a technical standard, Data Segmentation for Privacy, or DS4P, now permits sensitive data requiring special handling to be segmented within a patient's record. Even with these developments, state-law requirements for patient consent remain daunting to navigate.

CONCLUSIONS

Although patient consent requirements make HIE challenging, providers' expressed worries about legal barriers to participating in HIE likely primarily reflect concerns that are economically motivated. Lowering the cost of HIE or increasing financial incentives may boost provider participation more than further reducing legal barriers.

摘要

未加标签

政策要点:从历史上看,除了经济和技术障碍外,州和联邦健康信息隐私法也被认为是美国扩大电子健康信息交换 (HIE) 的重大障碍。我们的审查发现,在过去的十年中,一些有益的发展缓解了 HIE 的法律障碍,尽管各州患者同意要求的差异仍然是一个挑战。如今,医疗保健提供者对 HIE 法律障碍的抱怨可能更好地理解为反映了对信息共享的经济和竞争风险的担忧。

背景

尽管长期以来人们一直认识到在医疗保健提供者之间电子交换患者健康信息的临床益处,但 HIE 的采用落后于电子健康记录的采用。联邦和州健康信息隐私法规定的障碍被认为是进展缓慢的主要原因。尽管出现了一些重要的法律发展,但近十年来,人们并没有对这些问题进行全面评估。

方法

分析联邦和州健康信息隐私法规和法规以及次要材料。

发现

尽管 HIE 仍然存在一些法律障碍,但许多障碍已经得到缓解——在某些情况下,仅仅通过更好地理解法律实际要求就可以得到缓解。现在很明显,《健康保险携带和责任法案》 (HIPAA) 并不妨碍出于治疗目的电子共享受保护的健康信息,并且不会追究妥善披露信息的提供者对收件人隐私违规的责任。联邦努力建立独特的患者标识符号码的失败确实通过抑制患者记录的最佳匹配来减缓 HIE,但根据《21 世纪治愈法案》 (21st Century Cures Act) 将采取其他行动来促进匹配。该法案还创建了法律架构,开始打击“信息阻塞”。联邦和州法律下患者同意要求的差异是 HIE 进展的最重要的剩余法律障碍。但是,最近放宽了与滥用药物治疗信息披露有关的联邦规则,并且数据分段隐私 (Data Segmentation for Privacy,或 DS4P) 的技术标准的开发现在允许在患者记录中对需要特殊处理的敏感数据进行分段。即使有了这些发展,州法律对患者同意的要求仍然令人望而却步。

结论

尽管患者同意要求使 HIE 具有挑战性,但提供者对参与 HIE 的法律障碍表示担忧,这可能主要反映了他们出于经济动机的担忧。降低 HIE 的成本或增加经济激励措施可能比进一步降低法律障碍更能提高提供者的参与度。

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