In today’s digital health landscape, data is a powerful tool for growth, innovation, and improved patient care. However, the complexities of handling, sharing, and commercializing healthcare and consumer data are not to be underestimated. Frier Levitt attorneys focus on helping healthcare providers, clinically integrated networks (CINs), independent practice associations (IPAs), pharmacies, and healthcare and technology organizations leverage their data to drive business success while maintaining compliance with federal and state laws.
Our team of experienced attorneys is well-versed in the intricate intersection of healthcare law, privacy regulations, intellectual property rights, and commercial transactions. We guide organizations through the nuanced requirements of HIPAA, FTC rules, state privacy laws, and fraud, waste and abuse considerations to ensure that data is handled permissibly, while also enabling organizations to unlock their full commercial potential.
Navigating the Healthcare Data Ecosystem
The healthcare industry is uniquely positioned to benefit from data-driven insights. CINs and other organizations that aggregate information often have access to vast pools of member data intended to be used in the context of value-based arrangements and to improve healthcare delivery, operational efficiency, and patient outcomes. But these large pools of data also present opportunities to leverage information in other ways. The ability to monetize and commercialize data can be a key driver of growth. However, data commercialization is not as simple as “selling” raw data; it requires curation, preparation, and a deep understanding of privacy laws and the potential for fraud, waste, and abuse, including violations of anti-kickback statutes.
We work closely with healthcare organizations to develop legally sound models for aggregating, curating, and commercializing data. Whether you are an independent practice, part of a CIN, an IPA, or another provider network, we can help you ensure that your data transactions meet both regulatory requirements and strategic goals.
Creating Legally Compliant Data Models
Aggregating and normalizing data is an essential step in preparing data for commercialization. Commercializing data means the sale or licensing of data in exchange for some form of remuneration, which may be monetary or service-based. For example, pharmaceutical companies often pay for data studies to establish the efficacy of their drugs or determine how their competitors are obtaining market-share. To accomplish this, these pharmaceutical companies may contract with data “curators” to perform complex analytical studies and deliver reports on data back to them. However, these curators need access to large quantities of usable data that has been aggregated and normalized to conduct their analyses. Curators will often seek to contract with medical practices or other health care provider groups to obtain access to data that they can use for their upstream dealings with pharmaceutical companies. All these relationships involve complex contractual arrangements that raise a variety of regulatory issues. Frier Levitt is experienced in structuring legally compliant contracts with vendors that protect and preserve your data rights while complying with HIPAA, state privacy laws, and federal regulations.
Data Warehouse Management
We provide guidance on creating data warehouses, which are often essential for storing and processing healthcare data. These warehouses are typically hosted by third-party vendors, and the relationships with those vendors must be carefully structured. Our attorneys ensure that the contractual agreements between your organization and third-party vendors preserve your data rights, create a framework for adequate privacy and security, and minimize liability.
Comprehensive Legal Expertise Across Multiple Disciplines
Handling the full legal spectrum of data transactions in healthcare requires deep expertise in several legal areas:
Ensuring compliance with federal and state privacy regulations that protect sensitive patient data and create measures for appropriate de-identification.
Addressing ownership and licensing issues related to the source data and the resultant data, and any insights or innovations that may be derived in the process.
Negotiating and drafting agreements for data transactions, third-party vendor relationships, and commercialization.
Navigating potential antitrust concerns in data sharing and aggregation, especially when dealing with large networks or collaborative efforts.
Why Choose Frier Levitt
Our healthcare data practice combines deep legal expertise with practical industry knowledge. We understand not only the legal nuances but also the business implications of data transactions, particularly in healthcare. We work with our clients to create legally compliant and strategically sound data models that enable growth and innovation.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
