Reduced Regulatory Burden Needed For Improved Interoperability
Reducing regulatory and administrative burden on health IT developers and providers is necessary to paving the way for interoperability in healthcare.
This sentiment came from HHS Deputy Secretary Eric Hargan at the ONC 2018 Annual Meeting last week.
“It is actually impossible to move to a future health system, the one that we need, one that pays for procedures rather than sickness, without a truly interoperable health IT system,” said Hargan. “Now, sadly, that remains in our future too. Like a value-based system, an interoperable system remains in our future.”
Achieving interoperability is a top priority among regulators and health IT developers alike as stakeholders push for more patient-centered care. Several federal initiatives — including the MyHealthEData initiative announced at HIMSS18 — are designed to give patients control over their EHRs.
“Patients need to be able to access their own records,” said Hargan. “Period. When they move to a new provider, they ought to be able to bring their records. Period. How all that happens is really up to you. And that is part of what the private sector brings to the table, which is the understanding of how we get to where we need to go.”
Application programming interfaces (APIs) present an opportunity to enable interoperability by allowing devices developed by different health IT companies to exchange data points.
As API development increases and more developers enter the healthcare sector, Hargan stressed that federal entities will need to avoid taking a prescriptive approach to regulation.
“The world of regulating health software is still a largely new one,” said Hargan. “We have to be careful to take a practical approach to regulate it, not having the heavy hand on people who are developing these apps, developing the software.”
FDA plans to take a flexible, risk-based approach to regulating the use of APIs and other innovations to ensure regulatory processes do not stall the development of apps that may help to enable interoperability.
“As Commissioner Gottlieb laid out, the hope is that this can reduce the time and the cost of market entry ensuring that appropriate patient safeguards are in place,” said Hargan. “Now overall we hope that this will encourage more developers, including those that are new to the health care space to translate digital advances into tools that benefit patients.”