Healthcare firms urge federal agencies and Congress to simplify as well as clarify several healthcare regulations all the time. Healthcare firms want frequent updates so the guidance in federal regulations keep up with the accelerated pace of healthcare technology. CVS and Amazon are two companies who want better regulations in two key areas.
The two key areas where healthcare executives, CVS, and Amazon say the current regulations and laws are hurting healthcare innovations. According to healthcare executive Drew Madden, a current Evergreen Healthcare partner and the former president of Nordic Consulting Partners, the key areas are the U.S. Food and Drug Administration approval process, and the Health Insurance Portability and Accountability Act (HIPAA). The FDA approval process protects the security and privacy of patient data. And Madden thinks HIPAA regulations are too ambiguous. Madden also thinks there’s too much indecisiveness when it comes to identifying the types of healthcare software to regulate.
HIPAA hit the healthcare scene in 1996, and the last update in the HIPAA Omnibus Rule was in 2010. That update strengthened security and privacy as well as enforcement procedures. But the people who design healthcare apps say the update didn’t simplify technical language or policy. Instead of giving compliance instructions, the update only offers compliance recommendations. The U.S. Department of Health and Human Services (HHS) sends healthcare app developers to the National Institute of Standards and Technology (NIST) for data encryption recommendations, according to Madden.
Madden thinks HIPAA often hinders healthcare innovations. Madden says the data gets locked in, and developers can’t use it for data analytics. Mr. Madden also thinks patients should have easy access to their healthcare data. He also thinks patients should be able to determine who they want to share their data with.
But federal regulations tend to be disjointed, so federal officials walk a fine line when it comes to enforcing healthcare regulations. Mr. Drew Madden believes patient records should go where the patient goes without the red tape. That change will stop some of the unnecessary and expensive medical procedures that happen daily. He also said developing timely healthcare regulations is important to new healthcare app developers. New healthcare apps will make patient care an easier process, according to Madden.