The transformation from paper to electronic recordkeeping for the healthcare industry has occurred simultaneously with the shift to cloud-based computing, hosted software and data storage. The old world of HIPAA, one covered entity to one business associate, is giving way to the spontaneous emergence of health information exchanges, accountable care organizations, and other new entities and organizational structures, where a multitude of health care service providers are collaborating with vendors for the delivery of care to the population.
Accountable care depends, in part, on the benchmarking of large amounts of data in a diverse number of articulated data sets, raising questions from patient privacy to risk of anti-trust violations. The existence of large amounts of identifiable electronic health information presents some of the most intriguing ethical questions, to which our legal system has never before faced. Medical devices and implants are beginning to transmit electronic data into servers and repositories, resulting in ever increasing aggregation of health data, integration of bio-specimen repositories and clinical data warehouses, opportunities to incorporate genomic information into health records, personalized medicine, and an exponential expansion of knowledge and innovation around the delivery of care.
These trends present novel questions in Stark, anti-kickback, HIPAA, Common Law, privacy rights, medical licensing, and other areas of regulatory compliance. Are we ready for the ethical questions being triggered by advances in healthcare that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy?