By

Alan Kusinitz
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidanc
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Last week was the first offering of AAMI’s course on Agile Software Methods Compliance. Approximately 30 students attended from a wide range of medical device manufacturers including software engineers, quality, compliance, and regulatory managers. As a first offering this level of enrollment shows the high interest in more efficient and effective approaches to medical device...
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The EU Commission published “Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices.” This clarifies and strengthens the criteria for certifying (and auditing) notified bodies, and the criteria that the notified bodies have to use in assessing companies and products. The main changes...
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The FDA Safety and Innovation Act (FDASIA) workgroup completed its work and made its draft recommendations in September. The recommendations include: HIT should not be regulated except in cases where there is risk to the patient, a patient-safety risk framework should be used to allow application of regulatory oversight by risk, vendors should be required...
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The Therapeutic Goods Administration of the Australian Department of Health released a document on 13-Sep-2013 entitled “Regulation of medical software and mobile medical ‘apps’.”  This explains at a high level Australia’s approach to regulation of medical software.  It indicates a risk based approach is taken and that all medical devices are expected to meet the...
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The link provided is to a YouTube video by Henrik Kniberg on Agile Methods on key concepts focused on product ownership. Youtube – Agile Methods
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FDA CDRH has increased its focus on networked medical devices, Health IT, wireless technologies, and telemedicine.  They have established a web page provide an overview which then has links to pages related to Mobile Medical Apps, Medical Device Data Systems, Home Health and Consumer Device, Health IT, and wireless medical devices.
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FDA has recognized a total of 25 standards on medical device interoperability and cybersecurity. These standards can be categorized into 3 groups: Risk management standards for a connected and networked environment (IEC 80001 series and ASTM F2761-09) Interoperability standards that establish nomenclature, frameworks, and medical device specific communications, including system and software lifecycle processes (ISO/IEEE...
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The final version of the ONC plan that has the objectives to use health IT to make care safer and to continuously improve the safety of health IT. The document can be viewed here: onc_patient_safety_plan
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ONC guidance on annual surveillance plans by authorized certification bodies. Authorized Certification Bodies are expected to conduct surveillance on EHRs that they have certified. This guidance provides the priorities for topics to assess in the surveillance plan. Safety-related capabilities and security capabilities are two of the four areas for priority identified in this guidance. onc_surveillance_plan_guidance
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ONC contract with the Joint Commission to investigate health IT-related safety events. The purpose of this contract is to ensure that there is an early detection system on health IT-related safety issues, including those associated with EHRs. The document can be viewed at the following link: ONC_tjc_contract
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ICS-CERT is issuing this alert to provide early notice of a report of a hard-coded password vulnerability affecting roughly 300 medical devices across approximately 40 vendors. The document can be viewed at the following link: ICS-CERT_alert_med_dev
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NIST was directed to prepare a cybersecurity framework for critical infrastructure in Presidential Executive Order 13636. Healthcare was identified as one of the areas with critical infrastructure. This draft for comment is only an outline of the framework. NIST_draft_outline_cybersecurity_framework
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/docs/FDACybersecuritySafetyCommunication061413.pdf
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/docs/FDACybersecuritySafetyCommunication061413.pdf
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FDA issued a compliance letter to a company distributing an uncleared Mobile App for reading urine analysis strips on May 21, 2013. The full text of this letter is on our warning letter page.
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Brian Pate of SoftwareCPR now leads our specialized validation services for Mobile Medical Apps (MMApps), including our own simulator-based testing and automated unit and functional testing. For mobile apps that are regulated medical devices, we provide full design control and premarket submission support by compliance and validation experts with specific mobile app technical knowledge that...
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How Health IT will be regulated was being discussed by the U.S. government in February. A Health IT Patient Safety Action & Surveillance Plan was circulated by the Office of the National Coordinator for HIT (ONC) in December and is at the link provided. https://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf A report on An Oversight Framework for Assuring Patient Safety in...
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The total number of FDA software, computer system, and electronic records warning letters in 2012 is approximately 30 which is up from 18 in 2011 and fewer in 2009 and 2010. This is based on the keyword searches we perform on a regular basis but is not guaranteed to be comprehensive.
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A workshop with approximately 80 invited medical wireless experts was held in October 2012. This report, at the link provided, documents the discussion and outcomes of this workshop. A follow-up meeting is planned for March 2013. 2012_Wireless_Workshop_Publication
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http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdf
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This is one of the first mobile medical app recallsl we have seen posted. It is for an app that was only intended to be released in Brazil but was published on the iPhone store and available in the U.S. Its intended use is diabetes education. The full recall excerpt is available on our Recalls...
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The Global Harmonization Task Force revision of its guidance on Essential Principles of Safety and Performance of Medical Devices is at the link provided. GHTF Essential Principles. It includes requirements for software that are similar to the European Union’s essential requirements relating to software.
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A 2003 computer science thesis done at the University of York entitled “The Safety of Software — Constructing and Assuring Arguments” is at the link provided. Software Safety Cases – PhD Thesis
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