ONC 2015 IT Certification Criteria.

ONC. 2015 Edition Health IT Certification Criteria intended to increase interoperability. On October 6, the Office of the National Coordinator for Health IT (ONC) published the final rule for the 2015 Edition Health IT Certification Criteria intended to increase interoperability – a secure but seamless flow of electronic health information – and improve transparency and competition in the health IT marketplace. On the same date, the Centers for Medicare and Medicaid Services (CMS) published a final rule that specifies the requirements that eligible providers and hospitals must meet to qualify for Electronic Health Record (EHR) incentive payments and solicits feedback about the Electronic Health Record (EHR) Incentive Programs going forward.

Incorporation of UDIs into electronic health information is a critical cornerstone of the FDA’s plan to strengthen our National Medical Device Postmarket Surveillance system. Although full implementation of the unique device identification system will take several years, the inclusion of UDIs for implantable devices as part of EHR certification criteria and the CCDS are pivotal to developing the infrastructure needed to incorporate standard, structured device information into Health IT.

SoftwareCPR Training Courses:

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

Register Now


 

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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