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HIPAA Security Rule Explained: What Connected Device Manufacturers Must Know

Complete guide to the HIPAA Security Rule for medical device companies — covering administrative, physical, and technical safeguards, business associate obligations, and enforcement trends.

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The Connected Medical Device Knowledge Graph

Visualize how Design Controls (ISO 13485 / QMSR), Risk Management (ISO 14971), Software (IEC 62304), and FDA Cybersecurity (Section 524B) connect to guide your 510(k) or PMA journey.

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Knowledge Center

58 Articles

Medical Device Evolution Timeline

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2010

Implantable Miniature Telescope

Small telescope implant for end-stage macular degeneration

2010

Femtosecond Laser Cataract Surgery

FDA 510(k) clearance (K094052) for LenSx femtosecond laser for cataract surgery - capsulotomy, corneal incisions, and lens fragmentation

2011

IMDRF Established

International Medical Device Regulators Forum founded to promote global harmonization

2011

Software as Medical Device

FDA recognizes standalone software as medical devices

2012

Picosecond Laser for Tattoo Removal

Picosecond lasers introduced for faster, more effective tattoo removal

2012

Picosecond Laser FDA Clearance

Cynosure PicoSure receives first FDA 510(k) clearance for picosecond laser for tattoo removal and benign pigmented lesions (December 2012)

2012

FDA Safety and Innovation Act

FDASIA enhances device safety and establishes unique device identification (UDI)

2013

Laser Interstitial Thermal Therapy

FDA 510(k) clearance (K120561) for Monteris NeuroBlate LITT system for MRI-guided brain tumor ablation in April 2013

2013

UDI System Implementation

FDA begins implementation of Unique Device Identification system for device traceability

2013

Cybersecurity Guidance

FDA issues first cybersecurity guidance for connected devices

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Recent Past (2010-2025)

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HIPAA Security Rule Explained: What Connected Device Manufacturers Must Know

The Connected Medical Device Knowledge Graph

Knowledge Center

Standards Database

FDA Regulations

Quality Management Systems

Risk Management

Software Development

Cybersecurity & Data Security

Medical Electrical Equipment

Laser Safety

Usability Engineering

Implementation Guides

How-To Articles

Professional Development

Interactive Tools & Calculators

Medical Device Evolution Timeline

Implantable Miniature Telescope

Femtosecond Laser Cataract Surgery

IMDRF Established

Software as Medical Device

Picosecond Laser for Tattoo Removal

Picosecond Laser FDA Clearance

FDA Safety and Innovation Act

Laser Interstitial Thermal Therapy

UDI System Implementation

Cybersecurity Guidance

Medical Device Evolution Timeline

Implantable Miniature Telescope

Femtosecond Laser Cataract Surgery

IMDRF Established

Software as Medical Device

Picosecond Laser for Tattoo Removal

Picosecond Laser FDA Clearance

FDA Safety and Innovation Act

Laser Interstitial Thermal Therapy

UDI System Implementation

Cybersecurity Guidance