Jul 16, 2013

ראוי כי יפסק לאלתר פרויקט התעודה הביומטרית ויפסקו חגיגות הכספים המיותרים

על כך דובר בדיוני הועדה בכנסת, ההרכשה הראשונה היא הפגע הרע של כל ההנפקות ובביומטרי יותר מהכל - כבוד לערוץ 2 על הכנת התחקיר:
http://www.mako.co.il/news-israel/local/Article-5807ce59813ef31004.htm

About Us

We are Secret Codea fast-growing lead provider of consulting, and operation services in cyber risk and cloud defensive operations. Our experts operate in more than just a few countries around the world, helping businesses and organizations to learn and create a barrier to protect their own digital and monetarily data in the most complex threats in the digital Jungle of Cyber cloud security.

Our Motto: Providing personal service to each customer, suitable for the organization's needs. We mitigate the risks of cyber-attacks. We work with small /medium-sized businesses, as well as corporates and enterprises. who look for the best cost-effective solutions. We help business management protect their business assets in the safest and most secure way.

FDA Medical Classification Check List

FDA – Software Classification Checklist (CDS / SaMD / Non-Device)

FDA Software Classification

Fill out this questionnaire for a single software function to get a preliminary classification.

Step 1 – Clinical intent

1. Is the function intended for prevention, diagnosis, treatment, or monitoring of a medical condition for a specific patient?

"No" = admin, workflow, analytics, wellness, etc.

Step 2 – Non-Device CDS criteria

2. Does the function acquire, process, or analyze medical images or raw signals (CT, MRI, EEG, ECG waveforms, etc.)?

If yes → typically SaMD / medical device.

3. Does it operate only on processed medical information (diagnoses, visit summaries, lab results, EMR data, guidelines) and not on raw signals/images?

Uses reports/results, not raw sensor data.

4. Does it provide recommendations or support to an HCP, while the HCP remains the final decision-maker (no autonomous clinical decision or automatic treatment)?

Autonomous diagnosis/treatment → device.

5. Can the HCP independently understand and review the basis for the recommendations (data used, rules/guidelines), without blindly relying on the system?

Transparency is key for Non-Device CDS.

Step 3 – Device type (if Device)

6. If the function is a medical device, is its primary purpose to provide clinical recommendations to an HCP (e.g., “recommended therapy is X”) rather than automatically performing a therapeutic action?

Yes = Device CDS; No = other SaMD.

Recreating Cybercloud Safeguarding Today

Jul 16, 2013

ראוי כי יפסק לאלתר פרויקט התעודה הביומטרית ויפסקו חגיגות הכספים המיותרים

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