The infrastructure of health information technology is generally scattered, as countless vendors offer a variety of products to physicians such as updated PACS systems. Patient safety is of the utmost importance in health care, and developers have to take that concern into consideration when creating technologies.
Because of this, new federal regulatory framework was introduced at the beginning of the month for health IT software and is being met with support from the Medical Imaging community, AuntMinnie.com reported. Nearly two weeks ago, the Office of the National Coordinator for Health IT and the Federal Communications Commission collaborated with the U.S. Food and Drug Administration to propose a three-tiered framework to standardize rising technologies.
Protecting the safety of patients
Called the Food and Drug Administration Safety and Innovation Act Health IT Report, it features the risk-based categorization and regulation of software, in addition to a number of initiatives meant to improve health IT overall. The language of the framework outlined the boundaries of agencies such as the FDA, ONC and FCC in the realm of regulating the development of new HIT. Currently, the FDA oversees the digital imaging informatics products and will continue to do so under the report.
“MITA [Medical Imaging and Technology Alliance] commends FDA for developing the framework, and we look forward to ongoing collaboration with FDA to address details of how it will actually operate,” said Gail Rodriguez, executive director of MITA, quoted by the news source.
One of the main focus areas that will be used to categorize health IT products will be the functions of the device and how they relate to patient safety. It is believed that the services pose the greatest risks to the health of patients and therefore need to be regulated more than administrative and health management functions.
Securing data in HIT
With the recent revelation regarding the infamous Heartbleed Bug, the importance of encryption has been underscored. A high-level of encryption can be the most optimal safeguard that an IT department can implement for a medical practice. Yet, health care has been slow to adopt this kind of security protocol, which can leave it vulnerable to major data leaks.
“Many healthcare leaders believe that encrypting data increases the time to retrieve and review information which ultimately decreases efficiency. Although this isn’t the case anymore, it’s certainly a concern organizations still have,” said Elad Yoran, CEO of cloud encryption company Vaultive, quoted by HealthcareITNews.
A large portion of the issue’s complexity could be ironically attributed to the Health Insurance Portability and Accessibility Act. Normally used to protect patient health information and other sensitive medical data, HIPPA does not require electronic health records to be encrypted by IT specialists.
While the FDASIA report seeks to protect the physical being of patients, the encryption of health IT could contribute to the protection of health information. With innovative technologies seemingly popping up every day, federal regulations on encryption could benefit both providers and patients alike.
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Ronny Bachrach
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