HIPAA Modified Final Privacy Rule

On August 14, 2002, the HIPAA final privacy rule 45 CFR Parts 160 and 164 were modified to respond to comments and to reduce the administrative burden of the rule.  A copy of the new rule can be view here:  HIPAA Modified Final Privacy Rule 2002-08.

Medical Device manufacturers that produce devices that will maintain patient data in should be aware of HIPAA privacy and security requirements to assure appropriate features are incorporated in their devices to allow healthcare providers to comply with these aspects of HIPAA.

In addition, medical device, pharmaceutical and biologics manufacturers that collect individual patient information as part of research or clinical trials need to be aware of these rules as they can affect their internal systems and data handling to assure that the healthcare institutions that provide the patient information are compliant with the regulations.

SoftwareCPR® provides consulting and on-site and web based training in HIPAA privacy and security regulations. SoftwareCPR® also provides a HIPAA Roadmap with links to relevant educational documents to Premium subscribers.  Click here to subscribe.

SoftwareCPR Training Courses:

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

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

Registration Link:

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Being Agile & Yet Compliant (Public or Private)

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

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

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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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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