Big Data Continues to Shape Healthcare in 2014

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There is a rapid expansion of large and diverse data sets -- what is more commonly referred to as Big Data - as a result of the digitization of clinical and research data.

The premise of Big Data in healthcare is to collect, aggregate and analyze data that directly contributes to the quality and efficiency of patient care. For example, Big Data allows providers to isolate common readmission causes, allows payers to analyze care delivery inefficiencies that increase costs, and allows consumers to understand the ramifications of not taking their medications. Moreover, these data sources enable life sciences organizations to better understand the long-term value and performance of medical products and transform their approach to research, development and post-marketing surveillance.

Broadly speaking, the Big Data world for life science companies can be understood with three key themes:

    Liberating the Data;
    Understanding that all Big Data starts locally; and
    Watching those Docs.

Liberating the Data (Federal Efforts)

The government generally plays several roles in the development and management of Big Data, including that of an aggregator, payer and regulator. In 2009, the president released the “Memorandum on Transparency and Open Government,” which instructed all federal agencies to take specific actions to implement principles of transparency, participation and collaboration with regard to the data assets of the government. In 2010, the ACA further authorized HHS to release data to increase transparency in the markets for healthcare and market insurance. currently acts as a clearinghouse for all publicly available data sets. This portal launched with 30 data sets in 2010 and has now exceeded 1,000, which include roughly 15 percent from outside the federal government (e.g. 60 data sets from New York). Notable also is NIH’s commitment to fund six to eight Big Data Knowledge Centers of Excellence for four years and the International HapMap Project, which is a multicountry effort to identify and catalog human genetic similarities and differences.

Avalere expects that in 2014, federal and state governments, as well as groups like PCORI, will increase efforts to build new data infrastructures. In parallel, we expect strong advocacy to ensure that the quality of the data and its availability consider the needs of all stakeholders.

All Data is Local (State Initiatives)

Eleven states have already established all payer claims databases (APCD), and five states are in the process of creating one. Twenty-one other states have expressed a strong interest in establishing these sources, which are intended to assess and understand healthcare utilization trends, provide greater transparency on healthcare costs, support rate setting, and facilitate research to improve care quality. With the exchanges going online, further focus exists to ensure the delivery of the right data on the quality of care delivered. An emerging role in state Health Information Exchanges (HIE) is likely to encompass these all payer claims databases and other data sources.

Shareable electronic health records (EHR) also are addressing care coordination challenges by keeping a single consolidated record for each patient in a file that is accessible by all necessary parties. APCDs and HIEs have the potential to enhance existing databases with clinical information for quality and outcomes reporting. These efforts support a more localized strategy to data collection and the ability to create compelling research answering the age-old question by providers and state lawmakers: “What is happening in my backyard?”

Watch Those Docs (Professional Societies and the Clinical Data Registries)

Finally, Avalere expects a resurgence of professional societies building clinical data registries, sparked by continued SGR reform activity and increased EHR adoption. The American Taxpayer Relief Act outlined a new process through which physicians could meet federal quality reporting programs, by participating in a quality clinical data registry starting in 2014. In addition to conducting comparative effectiveness studies and monitoring product safety, these registries could measure the quality and cost of health care and test alternative payment models while serving as a means for a research collaborative in target areas, such as cardiology, endocrinology, orthopedics, rheumatology, gastroenterology and oncology. Specifically for the device community, these registries and their link into both FDA post-marketing and CMS coverage requirements will further support the growth of a national device surveillance system and set the national platform for ongoing evidence generation in a real world setting.

For more on this topic, Avalere will host several Big Data webinars this year, and we will present on similar topics at ISPOR this fall. For more information on Big Data now, contact Chris Boone, at

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