Increased access to health research data allows scientists and researchers to uncover new findings about diseases and treatments they might not have had access to before. This data, based on genomic markers, is the key piece to medicine-making and patient diagnosing.

In a recent study, researchers at斯坦福大学were able to break the world record of diagnosing a patient with a rare disease, in five hours and two minutes. By contrast, a typical diagnosis of rare diseases could take up to four years – and children typically must waitsix to eight years在被诊断之前。

缩短诊断时间表显然是生活更长，更健康的生活的关键因素。

The hurdle to speeding the pace of diagnosis is that health data is often held and accessed by a single group or organization (“silos,” in other words), and patient confidentiality makes data-sharing problematic. To overcome this hurdle, researchers and organizations are leaning into a relatively new method of health data management, by establishing trusted research environments (TREs).

TRE is becoming a commonly used acronym among the science and research community. In general, a TRE is a centralized computing database that securely holds data and allows users to gain access for analysis. TREs are only accessed by approved researchers and no data ever leaves the location. Because data stays put, the risk of patient confidentiality is reduced.

这与研究人员访问数据的传统方式完全不同。从历史上看，研究人员不得不将整个数据集下载到他们的计算机上，以便研究发现。以这种方式传输和释放数据也会增加安全问题的风险，即使个人已经被识别。此外，此方法需要大量时间 - 可以更好地用于分析临床数据集的时间。

Why the shift?

The COVID-19 pandemic revealed that patient clinical data availability and standardization was key to finding out more about the virus, and how to target it head-on. Researchers from all over the world were running experiments, analyzing their findings, collecting clinical data sets, and reporting on their outcomes.

During this time, organizations became more aware of the pressing need for a new way to manage health data. Specifically, the UK Health Security Agency started collecting whole genome sequencing back in 2020 for COVID-infected patients. Recently the agency has just passed one million genomes在他们的数据库中，这导致了有关病毒及其变体的许多发现和发现。这些发现随后与其他国家共享，以使世界受益。

有限访问的全球影响

TREs are becoming the architectural backbone for health data in many research organizations. While this is a step in the right direction, many TREs still can’t speak to colleagues from other organizations, or even other departments within their own organization.

For example, some universities have their own research departments, each with its own TRE. There have been unfortunately common situations where TREs that are only a wall apart in an organization can’t “speak” to one another. Without this ability, it is impossible totake full advantage of a TRE.

随着基因组部门的继续增长，Tres的能力 communicate will allow researchers and scientists to effectively collaborate to overcome life threatening diseases and diagnosis by breaking down the “silos” of health data.

That doesn’t mean moving data. Life sciences data sets are too large to move efficiently – and to complicate matters, many data security regulations forbid data to leave an organization, state or nation. Consequently, it is estimated that as much as80–90 percentof important datasets are simply unavailable to research.

需要的是从孤岛中的数据集中化转变为允许数据共享的手段in situwith the organizations that gathered it in the first place. No alternative is as promising for research.

什么构成值得信赖的研究环境？

There are several factors that organizations need to consider when they set off on the challenge of developing a trusted research environment. The UK Health Data Research Alliance has applied the Five Safes framework which is comprised ofsafe people, safe projects, safe settings, safe data and safe output,to TREs. What follows is an overview of those components.

1.安全的人

Users need to be approved and have the appropriate credentials to access the health data. Individuals should not be trying to re-identify individuals, as that would be a breach of patient confidentiality, or give another party access through their credentials. Researchers and scientists must be properly trained on using the TRE platform.

2.安全项目

即使TRE拥有安全和敏感的信息，必须使用的数据必须是相关的，并且可以用来积极地使公共卫生受益。为了实现这一目标，TRE必须进行审核以确保合规性。

3. Safe setting s

Cloud technology should never let data leave the database or export any findings to the users. Researchers should have the ability to bring in their own algorithms for analysis, but any tools that are imputed into the system must be contained in “airlock” mode. This feature allows for tools to be scanned so that the security of the TRE is not affected. Ensuring safe setting s also means that the users are tracked on their activity to make sure that the researchers and their work are approved and appropriate.

4. Safe data

Data within the TRE must be secure and safe, so that patients are de-identified and there is no possibility of researchers re-identifying the information. The quality of data has to be cleaned and verified as well, so that the appropriate data can be relevant to the approved project. The value of safe data can open up newresearch opportunities that will benefit the general public.

5. Safe outputs

As mentioned inSafe setting s , TREs must have barriers in place between the database and the researchers that are accessing the data. Barrie r s (or “airlocks”) are implemented so that the system can track requests and transactions from both sides to ensure everything is approved, secure and safe.

When TREs meet all five of these requirements, organizations are enabling a fully trusted research environment.

Conclusion

Genomic health data brings unique challenges when it comes to storage, management, analysis and collaboration, due both to the scale of the datasets and the sensitivity of what’s contained in them. TREs are becoming the architectural structure to bridge the gap for health data so that the information can be scaled and secured.