The Patient Protection and Affordable Care Act (“ACA”), viewed by many as the largest overhaul of health care in the United States to date, has brought about a time of great change. The health care industry has never been more complex, and concerns about the cost of, access to, and quality of health care have never been more pressing. In order for the health care system to work under the new requirements brought about by the ACA, we need innovators to design new business models and devices that will revolutionize the health care industry. However, the health care industry is highly regulated. As innovators begin to take advantage of the opportunities provided by the ACA, they must be prepared to work within the parameters of the many laws that strictly regulate the health care industry.

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