Mar 8, 2011

סמארטפונים ופרטיות המידע

Ynet

כתבה שכדאי להשקיע מעט זמן לקרוא נוגעת רק בהיבט אחד של סכנות פרטיות המידע במכשירי סמארטפון חדישים.
הכתבה עוסקת במידע הנאגר יחד עם תמונה שמבצעים בטלפונים בחדישים, המידע הנ"ל נגיש לכל אחד ברגע שאנו משתפים אותו עם גולשים אחרים באינטרנט.
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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

Mar 8, 2011

סמארטפונים ופרטיות המידע

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