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Sep

FDA Software Precertification Pilot Ends

September 27, 2022John MurrayBlog

In September 2022, the FDA Software Precertification Pilot Ends, or has officially “completed” the Software Precertification (Pre-Cert) Pilot Program. See: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program?utm_medium=email&utm_source=govdelivery The pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of...

Sep

September 2021 Standards Navigator Report

September 29, 2021Sherman EaglesBlog, StdNav

This September 2021 Standards Navigator Report content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, our report keeps you...

Sep

FDA Digital Transformation

September 23, 2021John MurrayBlog

FDA’s Digital Transformation and the regulation of Medical Device Cybersecurity? I read the recent FDA post that discussed the FDA’s Digital Transformation: “Today, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT).” Then I was reading...

Apr

FDA Modifying Medical Device Classifications

April 19, 2021John MurrayBlog

The FDA is officially modifying medical device classifications for some software functions. On April 19, 2021, the agency published a “final” rule that updates eight classification regulations by amending these regulations to exclude software functions that no longer fall within the device definition under 201(h) of the FD&C Act. With this final rule, FDA is amending the...

Nov

FDA’s Digital Health “Ask A Question” Portal

November 14, 2019John MurrayBlog

Do you have a question about FDA Digital Health Regulatory Policy? FDA’s Center for Devices and Radiological Health has a resource to help. I know from personal experience that the Digital Health Team (DHT) at FDA focuses a lot of energy and effort on answering these questions in an effective and efficient manner. During my...

Sep

FDA Releases Digital Health Guidances

September 26, 2019John MurrayNews

The U.S. Food and Drug Administration released a suite of “Digital Health” guidances. The guidances issued today are a continuation of the Agencies efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act. The first guidance announced is Clinical Decision Support Software, a revised...

Jan

FDA Digital Health Precertification (Pre-Cert) update

January 19, 2019Alan KusinitzNews

FDA is entering the test phase of its Digital Health Precertification (Pre-Cert) Pilot Program. General information on this program can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm including FAQs at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm577330.htm Milestones and next steps can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm584020.htm Generally, this program is for some of what FDA refers to as Software as a Medical Device (SaMD). ...

Jan

Verily Study Watch receives 510(k) clearance from FDA

January 18, 2019Brian PateBlog

The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems. The idea is that the Verily watch would be worn similar (or as!) a consumer device...

Sep

August 2018 Standards Navigator Report

September 7, 2018Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. Standards and Regulatory Activity Overview Medical device software Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health informatics, as well as the Member Bodies of ISO/TC 210, Quality management...

Aug

FDA Regulation of Mobile Medical Apps

August 1, 2018Amy SellersBlog

The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate...

Jul

FDA Examples of Cleared Apps

July 27, 2018Jordan PateNews

FDA provides examples of cleared Mobile Medical Apps.

Jul

FDA Software Precertification News

July 27, 2018Amy SellersBlog

Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...

Jul

FDA Clears Home Urinalysis Using Smartphones

July 27, 2018Jordan PateNews

Dip.io was cleared for clinical urinalysis. The device includes test strips and a color coded card that is readable by smartphone to provide a result for several conditions including infection.

Dec

FDA New Digital Health Policy Statement

December 9, 2017Alan KusinitzNews

On December 7, 2017, FDA Commissioner Scott Gottlieb, M.D., released the statement, “Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation.” This statement announces the release of several new draft and final guidances as part of the FDA’s Health Innovation Action Plan published previously. The new guidances are posted separately...

Dec

FDA Digital Health Innovation Action Plan

December 8, 2017Alan KusinitzNews

Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program. Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.

Dec

FDA Digital Health Webpage

December 1, 2017Alan KusinitzNews

The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.

Oct

FDA MDDS – Still Confusing After All This Time

October 31, 2017Alan KusinitzBlog

FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...

Aug

FDA Digital Health Precert Pilot FAQ

August 9, 2017Amy SellersNews

The FDA published a FAQ for companies that may be interested in participating in the Digital Health Software Precertification Program.

Aug

FDA Digital Health Precert Transcript and Video

August 3, 2017Amy SellersNews

The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.

Aug

FDA Digital Health Precert Meeting Summary

August 3, 2017Brian PateNews

"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"

Jan

US ONC Health IT Certification

January 29, 2017Jordan PateNews

The U.S. government established the Office of the National Coordinator for Health Information Technology (ONC) in 2004 and increased its role significantly in 2009 to promote and certify certain aspects of Health IT, including electronic medical record systems. Although a voluntary program, certification is required to access a number of financial incentives. This is entirely...

Jan

$Jan 2017 SoftwareCPR Standards Landscape$

January 17, 2017Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator and Standards Navigators PLUS subscribers. See our Subscribe page for information on subscriptions. This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how...

Sep

EU Court Software Case

September 13, 2016Alan KusinitzNews

National Law Review discusses a case before the EU Court of Justice to decide if medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device. The manufacturer prefers it to be considered a medical device to avoid more onerous requirements if it is not treated that way.

Jun

EU IVD Trilogue Agreement

June 23, 2016Alan KusinitzNews

See the item on the MDR Trilogue Agreement for further explanation. The text for the IVD draft is a the link provided here: EU IVDR.

Oct

FDA CDRH Learn Health IT & Cybersecurity Training

October 5, 2015Alan KusinitzNews

FDA has a series of training videos and slide presentations referred to as CDRHLearn. Under the Special Technical Topics is an IT and Software Section which lists 3 topics: Digital Health, Premarket Cybersecurity Information, and CDRH Regulated Software.

Sep

FBI Cybersecurity Warning for Medical Devices

September 23, 2015Alan KusinitzNews

The U.S. FBI issued a Public Service Announcement on the Internet of Things that includes, “Criminals can also gain access to unprotected devices used in home health care, such as those used to collect and transmit personal monitoring data or time-dispense medicines. Once criminals have breached such devices, they have access to any personal or...

Sep

FDA CDRH Learn HealthIT and Cybersecurity Modules

September 20, 2015Alan KusinitzNews

FDA maintains a webpage for its educational modules referred to as “CDRH Learn.” Specialty Technical Topics provides a list with a section for IT and Software that includes three modules on Digital Health, Cybersecurity information in premarket submissions, and CDRH regulated software.

Jun

FDA UDI Rule Webpage

June 7, 2015Alan KusinitzNews

FDA issued a final version of its Universal Device Identification rule in 2013 and this rule is posted in the softwarecpr.com library. FDA also created and updates a webpage devoted to implementation of this rule (which will take place over seven years with higher risk devices sooner and lower risk devices at the end).

Mar

ONC Prepub Proposed 2015 HIT Certification Reqs.

March 20, 2015Alan KusinitzNews

The draft of the US ONC proposed 2015 HealthIT ceritfication requirements rule is at the link provided. The final will be published March 30, 2015. This new version requires use of a quality system and states: “….QMS established by the federal government and SDOs include FDA’s quality system regulation in 21 CFR part 820, ISO...

Feb

HealthIT ONC Quality System Standard Presentation

February 6, 2015Alan KusinitzNews

HIT Implementation, Usability and Safety Workgroup meeting on Friday, February 6, 2015 – SoftwareCPR® Partners Sherman Eagles and Alan Kusinitz gave a presentation at ONC’s request with recommendations on an approach to HealthIT provider quality systems regulation and standards. In addition to providing background on quality systems, SoftwareCPR® recommended that a standard or guidance be...

Feb

FDA Final MDDS Guidance

February 6, 2015Alan KusinitzNews

FDA issued a final version of its guidance for “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The document is dated February 9, 2015, although it was issued several days prior. This guidance is very significant as it states FDA is exercising discretion and not requiring compliance to the recent...

Feb

HealthIT Office of National Coordinator Calender

February 6, 2015Alan KusinitzNews

The Federal Advisory Committee calendar of meetings is at the link provided. Attendance or downloading of material for most of these meetings is open to the public.

Feb

AAMI HealthIT Quality Management Principles

February 2, 2015Alan KusinitzNews

AAMI has filed a Project Initiation Notice with ANSI for a new standard on Application of Quality Management Principles and Practices to Health IT. The notice was published in the ANSI Standards Action publication on January 23. The notice is reproduced below. BSR/AAMI HIT2000-201x, Application of Quality Management Principles and Practices to Health IT Stakeholders:...

Dec

Safety Assurance for EHR Article

December 20, 2014Alan KusinitzNews

The link provided is to a 2013 article entitled: “Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol.” Safety Assurance for EHR Article

Jun

ONC Health IT 10-year Interoperability Concept

June 13, 2014Jordan PateNews

See the ONC 10-year roadmap to achieving a “learning health system” based on an interoperable health IT ecosystem at the link provided. ONC 10 year Interoperability Concept Paper

Jun

SoftwareCPR Standards Summary May 2014

June 13, 2014Alan KusinitzNews

A number of draft standards were released for comment, including including several related to specific security for medical devices and Health IT: AAMI TIR38 – AAMI Medical device safety assurance case guidance IEC Health SW Standards Framework ISO 27799 Health informatics “Information management in health using ISO/IEC 27002” IEC TR 80001-2-8, Application of risk management...

Apr

FDASIA Draft Health IT Regulatory Strategy

April 3, 2014Alan KusinitzNews

The FDA released its anticpated draft report on regulation of Health IT. This report includes a risk-based regulatory framework for health information technology (health IT) that is a step towards clarifying what software will be actively regulated by FDA. The report was developed by the U.S. Food and Drug Administration in coordination with the Health...

Mar

ONC Proposed 2015 HealthIT EHR Rule

March 6, 2014Alan KusinitzNews

The Office of National Coordinator for Health Information Technology published a proposed rule for Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements. The proposed rule eliminates the “complete EHR” designation, separates the content and transport certification criteria and announces a more frequent certification rule making process. The proposed rule also...

Feb

IT Network Assessment Article using IEC 80001-1

February 25, 2014Alan KusinitzNews

AAMI recently published “Assessing a Hospital’s Medical IT Network Risk Management Practice with 80001-1” in Biomedical Instrumentation & Technology (BI&T). The article reports on an actual hospital network/health IT assessment using 80001-1 as one of the tools for the assessment.

Feb

Health IT Safety Guides

February 9, 2014Alan KusinitzNews

A new set of guides and interactive tools to help health care providers more safely use electronic health information technology products, such as electronic health records (EHRs), are now available at the link provided. The Office of the National Coordinator for Health Information Technology (ONC) at HHS released the Safety Assurance Factors for EHR Resilience...

Jan

U.S. Government Health IT Website

January 5, 2014Alan KusinitzNews

The U.S. Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) maintains a website at the link provided. This website includes information and updates on Health IT and Electronic Medical Records programs for software that often is not considered a Medical Device and not regulated by the U.S. FDA.

Sep

FDASIA Workgroup Recommendations

September 25, 2013Alan KusinitzNews

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...

Aug

FDA Connected Health Initiative

August 15, 2013Alan KusinitzNews

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.

Jul

U.S. HHS Dep. Health IT Safety and Surveillance Plan

July 2, 2013Jordan PateNews

The U.S. Department of Health and Human Services (of which FDA is a part) published “Health Information Technology Patient Safety Action & Surveillance Plan.” The plan defines several types of action: Learn – mainly monitoring of safety of Health IT in the field Improve – Investigate adverse events and take corrective action. Set safety priorities...

Mar

Health IT U.S. Regulation Update

March 17, 2013Alan KusinitzNews

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...

Oct

FCC Report on Mobile Health

October 12, 2012Alan KusinitzNews

An FCC mHealth task force reported recommendations to government and industry to address barriers to rapid mHealth deployment. See the link provided: FCC 2012 Mhealth Taskforce Recommendations.

May

AAMI Software and Health Information Technology

May 16, 2012Alan KusinitzNews

The Association for the Advancement of Medical Instrumentation (AAMI) is reorganizing its committee structure related to Software, Health IT, networks and related topics by forming a Software and Health Information Technology (SWIT) committee to oversee all related standards activities. The current plan is that this committee will coordinate all work in the Software, IT, MDDS,...

Mar

FDA Regulation of Health IT Systems Testimony

March 5, 2010Alan KusinitzNews

Attached is a pdf of the testimony of FDA’s Director of CDRH Jeff Shuren regarding Health Information Technology Policy. It discusses the need for active regulation FDA regulation, the possible approaches to regulation, and the regulatory basis for this. The Appendix provides some examples of adverse events associated with such systems. It identifies four categories:...

Jan

Electronic Health Record 42 CFR Parts 412

January 13, 2010Alan KusinitzNews

The link provided is for “42 CFR Parts 412, et al. Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule.” 42CFR_412_EHR_HITECH

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