“Hiding within those mounds of data is knowledge that could change the life of a patient, or change the world.” – Atul Butte, Stanford
“Information is the oil of the 21st century, and analytics is the combustion engine” – Peter Sondergaard, Senior Vice President, Gartner
With rare exception, healthcare providers, such as medical practices, Clinically Integrated Networks (CINS), hospitals and pharmacies, that understand and control their data, will be the only ones that thrive over the next few years. With the transition to value-based care, physicians and other providers will be judged and paid, at least in part, on their performance, in terms of both cost and outcome measures. Providers must understand the value of data to their own practice operations, as well as to third-parties, such as pharmaceutical companies, insurers, and self-insured employers.
Medical practices, in particular, accumulate massive quantities of data every day, merely by treating patients, entering information into the patient’s medical record, and submitting claims. However, without any additional action, this data is in a raw form, which means it is not aggregated, or “normalized,” and is difficult or impossible to analyze meaningfully. How many of the practice’s cardiac patients admitted to the hospital for an acute MI are discharged on an ace inhibitor? These types of questions can only be answered by practitioners with a deep understanding of their data.
Frier Levitt works with medical practices, CINs, IPAs, pharmacies and other networks of providers to develop legal models for aggregating data, working with third-parties to normalize and curate data, and negotiating legally compliant (e.g., consistent with HIPAA and state privacy laws) contracts for the commercialization of data. Handling the full legal spectrum of data transactions requires a deep understanding of privacy law, intellectual property law, contract law and even antitrust law, as well as broad industry experience. The attorneys at Frier Levitt have expertise in each of these areas and can counsel health care providers on the myriad issues raised in data transactions.
What is Frier Levitt’s role with respect to data aggregation?
Data aggregation often involves creating a data warehouse, typically in a data cloud hosted by a third-party. The contractual relationship with these third-parties requires an understanding and focus on a variety of issues meant to protect patient privacy, maintain the data in a safe and usable format, avoid inadvertently conferring intellectual property rights to the third-party, and negotiating an appropriate exit strategy. Creating a data warehouse may also involve the transfer of PHI from multiple provider entities (e.g., multiple medical practices, ancillary providers such as ASCs or laboratories, and hospitals). Having multiple sources requires careful review of a variety of federal and state laws in order to protect the interests of all parties concerned.
What is Frier Levitt’s role with respect to data commercialization?
Commercializing data means the sale or licensing of data in exchange for some form of remuneration. Remuneration may be monetary or service-based. For example, pharmaceutical companies often pay for data studies in order to establish the efficacy of their drugs, or determine how their competitors are obtaining market-share. Pharmaceutical companies may contract with third-party data “curators” to perform complex analytical studies. These curators need access to large quantities of usable data that has been aggregated and normalized. Curators will often seek to contract with medical practices or other health care providers to obtain access to this data. All of these relationships involve complex contractual arrangements that raise a variety of regulatory issues. Frier Levitt is well versed in these issues, and has substantial industry experience so that we understand what is standard practice and what is not.
How can Frier Levitt help providers avoid legal pitfalls?
Transmitting, storing and commercializing data involves a number of legal challenges, including the risk of inadvertent disclosure of PHI, the risk of inadvertently forfeiting intellectual property rights, and the risk of entering into an unfavorable commercialization agreement. Through our deep industry experience and knowledge, we can protect health care providers from these pitfalls.