Understanding the MEDTECH and SOFTWARE Acts

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Understanding the MEDTECH and SOFTWARE Acts

Health care software developers have enjoyed legislative autonomy for some time. Still, industry advocates have assumed a proactive stance in influencing pending regulations for recent medical technology innovations. The U.S. Food and Drug Administration (FDA) provided some regulation in the field, offering varying direction depending on who developers communicated with at the agency. Without established legislation, the industry existed in a state of legal limbo. Today, the MEDTECH and SOFTWARE acts embody the first legislative policies that provide regulation for new patient information technologies.

The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act

Care providers and medical technology developers collaborated to lobby for the MEDTECH Act, which streamlines software product launches. The act relaxes regulations for low-risk medical applications formerly supervised by the FDA.

Medical software technology advocates argued that deficient regulatory policies delayed advancement in the field. The group cited that arbitrary decision-making and vague laws increased software time to market and deterred developers from creating innovations that might improve public health. Supporters of the act argued that by easing restrictions on less risky software the FDA can free resources to evaluate and monitor high-risk medical software and devices.

MEDTECH exempts specific medical software from the Federal Food, Drug and Cosmetic Act, such as:

  • Electronic health records (EHRs)
  • Health care administrative software
  • Medical decision-making software
  • Patient wellness software
  • Software used to display, manipulate, or store medical information

Care providers use such software to manage administrative tasks such as billing and patient record keeping. Other programs help patients maintain healthy lifestyles, generate treatment recommendations, and allow providers to transfer, store and view information.

The guidelines used by FDA officials to assess medical software remain under development. For now, the agency makes decisions based on risk-and-benefit reports delivered by the U.S. Department of Health and Human Services.

The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act

The SOFTWARE Act describes regulatory exempt programs as applications that do not gather or evaluate information from test tubes, cultures or other devices that perform functions outside of patients’ physical bodies. Under the act, health software enjoys autonomy from FDA regulation, even when part of a medical device, unless the program makes patient treatment recommendations or performs high-risk tasks.

As an example, software that facilitates patient monitoring or medical device operation does not fall under act exemption. Conversely, programs that deliver wellness education or analyze general health information do fall under the act.

Medical software encompasses programs that produce information, requiring no further input or analysis by care providers. The act excludes native software for medical devices, as well as illness prevention and blood transfusion programs. Software used to manage administrative and operational tasks poses minimal risk to patients, and therefore remains exempt from FDA regulation. Any software that produces information that requires interpretation by a trained specialist remains governed by FDA regulations.

The FDA also differentiates medical devices from accessories. The SOFTWARE Act defines an accessory as a device or program that extends the use of existing medical equipment or program, such as components for:

  • Data management, not including components for active patient monitoring
  • Financial record administration and support
  • General health data analysis
  • Patient specific health information analysis
  • Recordkeeping and administrative workflow
  • Wellness education organization and presentation

Historically, the FDA has over regulated accessories due to designation as primary medical devices. The legislation frees medical accessories from this classification, allowing developers to deliver low-risk software with reduced legal requirements.

SOFTWARE eligible programs provide administrative, operational and financial support. Care providers use the technology in clinical, laboratory and administrative settings.

How Medical Software Improves Wellness Outcomes

Software innovations have transformed the medical field, allowing care providers to manage health data digitally and access information in real-time. The innovations have bolstered the informatics field, a discipline focused on health care data management. For instance, care providers use electronic health records (EHRs) to issue safer prescriptions and maintain precise patient records. EHRs allow care providers to develop comprehensive patient health overviews. During emergencies, the technology provides fast access to patient information.

Medical technology now serves as a digital watchdog, warning care providers and patients about drug interactions and offering practical treatment recommendations. Technology also helps informatics specialists maintain patient confidentiality. Linked prescription networks verify patient prescription information from the physicians’ instructions to the pharmacists’ delivery, reducing dispensing errors. Comprehensive EHR systems eliminate testing redundancies, reducing patient risk and discomfort. Medical software in itself does not improve patient outcomes. The effectiveness of these technologies rests in skilled and vigilant medical professionals.

Transitioning from manual to digital medical record-keeping represents a monumental undertaking that parallels the sweeping advancements brought forth by the industrial age. In this brave, new environment, care providers’ demand for health information technology specialists will continue to grow as caseloads rise and more institutions implement contemporary technologies.

Learn More

To learn to speak the language of health law and distinguish your role as a leader with specialized health care compliance expertise, look to pursue a Master in Health Law and Policy from Hofstra Law.


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