CMS is in a unique position to acquire and distribute some of the data— in a structured, beneficiary-controlled way— to enable innovative developers to provide valuable tools to American patients and families. This is a new and inadequately understood area, with implications for law, ethics, technology, finance and liability. CMS will need to address a number of challenges to identify its appropriate role in this new and unsettled environment. Beneficiaries — and the nation as a whole—will be best served if CMS works closely with both public agencies, private sector organizations, and the general public to develop models, policies, and standards that respond to these challenges.