Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know

Additionally, the Cures Act was groundbreaking in its promotion of interoperability and prohibition of information blocking. The ONC’s long-awaitedproposed ruleushers in the next phase of the Cures Act by adding substance to these provisions.

The proposed rule was released in March 2019 and provides for apublic commentperiod that expires on June 3, 2019. Following the public comment period, ONC will review feedback and eventually release the final rule, which could take another one to two years. According to theU.S. Department of Health and Human Services (HHS), the proposed rule “is designed to increase innovation and competition by giving patients and their healthcare providers secure access to health information and new tools, allowing for more choice in care and treatment.” In its promotion of access, exchange, and use of electronic health information (EHI), the proposed rule outlines seven exceptions to information blocking. It’s important for healthcare providers, healthcare systems, and vendors that are interested in promoting information sharing to review these exceptions during the public comment period to help ensure that they are sufficiently restrictive in the final rule.

为什么必须停止信息封锁?

The introduction of theHealth Information Technology for Economic and Clinical Health (HITECH) HITECH Act, provided federal subsidies for the adoption of EHRs. Although the legislation required that EHRs have interoperability functionality, it was less successful in promoting interoperability in practice. Further, the HITECH Act did not anticipate the extent to which widespread information blocking practices would limit interoperability. Now that most healthcare organizations have adopted EHRs, much of this information is siloed and it can be difficult to get the right information at the point of care. Siloed information also inhibits the ability to analyze data that can improve care delivery and financial and operational processes. The promise of vast amounts of health information can’t be realized until interoperability improves.

不存在更好的互操作性的一个原因很简单，就是很难让不同的系统有效地相互通信。然而，这也是由于信息封锁实践造成的。信息封锁实践可能基于组织政策，也可能是技术性的。Examples of organizational policy are:

1. 采取数据模型或模式是专有的立场，尽管数据汇编不受版权或其他知识产权法的保护这一事实早已确立。
2. Claiming that sharing EHI for treatment with a third-party provider is prohibited by HIPAA, when it is not.

技术信息阻塞的一个例子是没有使应用程序编程接口(api)随时可用。Whether intentional or not, information blocking practices can inhibit the sharing of critical healthcare information, with a range of negative consequences, including failure to coordinate care, unavailability of important clinical values at the point of care, and lack of the rich data needed to fully utilize analytic tools, benchmarking, and machine learning techniques.

The Seven Proposed Exceptions to Limiting Information Blocking

Following from the definition in the Cures Act, the proposed rule defines “information blocking” as “a practice that, except as required by law or covered by an exception…is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.”

《治愈法案》规定，对信息封锁的罚款最高可达100万美元。The proposed rule includesseven proposed exceptionsto information blocking which, if the required elements of the relevant exception are met would exempt the practice from enforcement. These seven exceptions are briefly outlined below.

1. Preventing Harm– An organization may engage in a practice that is reasonable and necessary to prevent physical harm to a patient or other person. The organization must have a reasonable basis to believe that its practice will directly and substantially reduce the likelihood of harm to a patient. The organization must have adopted a policy that addresses patient harm or make case by case findings that a disclosure of EHI could result in patient harm.
2. Promoting the Privacy of EHI– An organization may engage in a practice to protect the privacy of EHI. The organization must demonstrate a basis for its actions in HIPAA and other privacy laws.
3. Promoting the Security of EHI-组织可以采取措施保护EHI的安全。必须对实践进行严格的调整，以适应保护安全所必需的措施。
4. Recovering Costs Reasonably Incurred– An organization is permitted to require payment for the reasonable costs incurred in making EHI available.
5. Responding to Request that are Infeasible– An organization is permitted to decline a request for EHI access if it determines, using objective and verifiable criteria consistently applied, that the request is infeasible.
6. Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms-组织可以声称其技术或工艺受到知识产权法的保护，但是，该组织有义务以合理和非歧视性的条件向该技术或工艺提供许可。
7. Maintaining and Improving Health IT Performance– Allows for downtime that may make health IT and EHI temporarily unavailable in order to perform maintenance or upgrades.

贯穿例外情况的一致主题，即组织的做法必须是合理的和非歧视性的，必须始终如一地应用。世界杯葡萄牙vs加纳即时走地Health Catalyst通常认为这些例外都是定义良好且足够狭窄的。然而，有一些例外的方面应该被修改，以确保没有继续鼓励信息封锁实践的重大漏洞。

The Good

Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms: This exception addresses a problem that many data and analytics vendors encounter when working with some vendors or healthcare providers. When asked for access to a database, a vendor or healthcare provider may claim that providing access to data will infringe its intellectual property rights. The exception would create an obligation for the party receiving the request to respond to the requestor within 10 business days, and to offer a license to any technology or processes (such as databases, interface protocols) on reasonable and non-discriminatory terms, and at a reasonable cost. The language on reasonable cost is helpful because it could help to limit the practice of vendors charging prohibitive fees for access.

What to Watch Out For

组织可以使用一个或多个异常来证明信息阻塞实践的合理性，而且很难质疑这种异常的使用。These exceptions include:

Privacy and Security Exceptions-这些例外条款的起草范围相当广泛。医疗保健提供商或供应商可以声称，它不打算为了遵守HIPAA隐私或安全标准而共享EHI。虽然这种说法必须得到支持，但在实践中可能很难挑战这一立场。试图对这个问题“提起诉讼”，无论是从挑战不合理决定的基础的比喻意义上，还是提交信息封锁投诉，都可能太耗时、太昂贵，最终可能是无效的。

还有一种可能性是，一个组织将通过向提供者提供低质量的信息来“遵守”规则，而且这种类型的行为也很难挑战。

Responding to Requests That Are Infeasible-这是另一个可能被滥用的例外，因为它潜在的广泛范围。The exceptionstates, “an actor must demonstrate that complying with a request to access, exchange, or use EHI would impose a substantial burden on the actor that is unreasonable under the circumstances.” Although proving that a request poses a substantial burden takes into account several factors, such as the cost to comply, the type of information, financial and technical resources, these findings may prove very difficult to challenge, opening the door to misuse and continued information blocking. One of these factors is that the party must provide “comparable access,” but this could open the door to providing access that on its face appears comparable but in practice lacks the granularity, speed, or other attributes that would make the EHI useful.

In addition to these exceptions, there is a possibility that the reasonable cost provisions could be watered down in the final rule, opening the door for continued prohibitive charges for access.

Why This Matters

总的来说，提议的规则是促进互操作性的一个非常积极的发展，具有强大的、狭义定义的例外来限制信息阻塞实践。如果提议的规则以其当前的形式基本实现，它将减少信息阻塞并促进互操作性。然而，行业组织仍有可能试图推迟或稀释拟议中的规定。提议的规则已经被推迟了两年多，最终规则生效还需要一到两年的时间。医疗保健提供商、医疗保健系统和医疗保健IT供应商都应该关注以最强大的形式实现该规则。

减少信息阻塞将有助于医疗保健提供商和系统利用技术和服务来改进流程和患者护理，以及财务和运营流程，还将帮助医疗保健it供应商以更快的周期进行创新，以开发和部署这些技术和服务。一些供应商通过信息封锁和孤立数据来获取市场份额和增加进入壁垒，但这些做法最终会损害医疗保健系统和患者护理。

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