What are some of the challenges facing precision medicine and the Precision Medicine Initiative?

Precision medicine is a young and growing field. Many of the technologies that will be needed to meet the goals of the Precision Medicine Initiative are in the early stages of development or have not yet been developed. For example, researchers will need to find ways to standardize the collection of clinic and hospital data from more than 1 million volunteers around the country. They will also need to design databases to store large amounts of patient data efficiently.

The Precision Medicine Initiative also raises ethical, social, and legal issues. It will be critical to find ways to protect participants’ privacy and the confidentiality of their health information. Participants will need to understand the risks and benefits of participating in research, which means researchers will have to develop a rigorous process of informed consent.

Cost is also an issue with precision medicine. The Precision Medicine Initiative itself will cost many millions of dollars, and the ongoing initiative will require Congress to approve funding over multiple years. Technologies such as sequencing large amounts of DNA are expensive to carry out (although the cost of sequencing is decreasing quickly). Additionally, drugs that are developed to target a person's genetic or molecular characteristics are likely to be expensive. Reimbursement from third-party payers (such as private insurance companies) for these targeted drugs is also likely to become an issue.

If precision medicine approaches are to become part of routine healthcare, doctors and other healthcare providers will need to know more about molecular genetics and biochemistry. They will increasingly find themselves needing to interpret the results of genetic tests, understand how that information is relevant to treatment or prevention approaches, and convey this knowledge to patients.