The U.S. Food and Drug Administration intends to release guidelines for how it would govern mobile medical apps, according to a HealthcareITNews report.
President Barack Obama and Congress recently approved the bipartisan Food and Drug Administration Safety and Innovation Act, which gave the FDA clearance to regulate mobile medical apps. The bill allows the FDA to proceed with the guidelines for regulation rather than waiting for the Department of Health and Human Services' to complete framework for patient safety with health information technology.
The law also reauthorizes user feeds that the FDA collects from the drug and medical device industries, creates a new fee for generic drug sellers and improves the agency's oversight of safety regulations. While the law has received some support, not all parties approve. According to the report, the Health IT Now Coalition had lobbied to stop the FDA from issuing its guidelines, at least until the HHS report is completed. According to the report, the HHS report is to focus on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications that promote innovation, protects patient safety and avoids regular duplication.”
According to the report, the FDA does not intend to regulate all mobile apps, just those that act as medical devices or contribute to clinical decision-making processes.
President Barack Obama and Congress recently approved the bipartisan Food and Drug Administration Safety and Innovation Act, which gave the FDA clearance to regulate mobile medical apps. The bill allows the FDA to proceed with the guidelines for regulation rather than waiting for the Department of Health and Human Services' to complete framework for patient safety with health information technology.
The law also reauthorizes user feeds that the FDA collects from the drug and medical device industries, creates a new fee for generic drug sellers and improves the agency's oversight of safety regulations. While the law has received some support, not all parties approve. According to the report, the Health IT Now Coalition had lobbied to stop the FDA from issuing its guidelines, at least until the HHS report is completed. According to the report, the HHS report is to focus on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications that promote innovation, protects patient safety and avoids regular duplication.”
According to the report, the FDA does not intend to regulate all mobile apps, just those that act as medical devices or contribute to clinical decision-making processes.
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