How do we lower the cost of clinical research and drug development?

I had the opportunity to meet with Congressman Patrick Meehan (R-Pa) last week. In the past, we have had the opportunity to talk about homeland security, but this time we were discussing healthcare.

The Congressman was canvassing the life sciences industry for ideas on how to lower the cost of clinical research and drug development.  There were two topics that really struck home for me:

1. Healthcare Data Accessibility. (We need a Healthcare data library.)   

Given the current set of regulations concerning data sharing, which are primarily driven by the HIPAA and HITECH acts, are there changes to the current regulations that could make electronic healthcare information easier to access? 

The federal government’s recent efforts to incentivize information-sharing has been focused primarily on lowering the cost of the health care transaction.   There has been much progress and much investment in the creation of electronic record systems.  These systems and health information exchanges are lowering the transaction costs between the care providers, insurance claims processing, and payment systems.  What is needed now are stronger sharing incentives to create a Digital Health Information Library.  A Digital Health library would contain the history of the transactions that provide for even more opportunities to lower the cost of clinical research and development, drug development and patient outcomes.  We are a healthcare analytics company. In our experience, the cost of acquiring information is excessive.  There are government initiatives for data sharing like OpenFDA, CMS/VRDC, and other “Open Government” initiatives.  While we are supportive of these efforts, the level of sharing large data stores is still too complicated and is not optimized for business. 

2. Open Data Standards. (We need a data-sharing framework.)

Current regulations were designed to lower the cost of sharing information primarily to lower the cost of transactions (e.g. paying claims, ordering tests, prescriptions). There are standards to ensure that Private Health information (PHI) and Personally Identifiable information (PII) is protected by security technologies, processes, and techniques.  Through HHS and the office of the national coordinator, there are initiatives to define better data standards.  The incentives and grants that have been issued are having a positive effect on transforming the healthcare system to an electronic-based system, but the system still has very proprietary data definitions, which makes compatibility difficult.  What is needed is a more open set of data standards that will help enable a digital health economy.  This will reduce the cost of research and care and will improve quality.

Doug Dreyer
Senior Vice President, Advanced Solutions