hipaa 2013 - The Role of HIPAA in an Increasingly Unregulated and Under-Regulated World of Devices

Overview: If you are involved in the development, use, or management of devices and applications that are collecting or transmitting identified health care information, then you should be aware of how such devices may not be in compliance with Federal Statutes. New devices have been introduced, from smartphones with health data apps, to stand alone kiosks in grocery stores, all of these are collecting some form of health data in an unregulated and non-compliant way, add to this the proliferation in connected devices, and the lack of compliance is exploding.
Areas Covered in the Session:
What device and App vendors need to understand about HIPAA Privacy and Security in a world of cell phone apps and peripherals, and other new stand-alone devices, that collect, transmit, and store Patient Identified Medical Data
The unregulated roles that smartphone apps are playing in violating the Privacy and Security requirements under HIPAA and the potential for liabilities
Examples of potential HIPAA Violations in both apps and devices
Design requirements for smartphone applications and standalone medical diagnostic devices in a connected world
How to approach a HIPAA compliance view, approaches to HIPAA compliance audits, and best practices for App and Device Manufacturers
A Consumer Driven Model for HIPAA Compliance in connected applications and devices
Check List For App & Device Compliance
Who Will Benefit:
Smartphone App Developers
Connected Device Developers
Business People using these devices or deploying them in their businesses
Health Care Regulators
Health Care Attorneys
Dr. McGuinness is a seasoned professional in regulatory compliance, with significant experience in both public and private sector compliance for Privacy, Security/Safeguards, Application (and Systems), and Business Process compliance. He has extensive 12 years’ experience in HIPAA regulation and compliance implementation, Co-founding Chairman of the HIPAA Conformance Certification Organization, certifications in HIPAA Privacy and Security, certified Chief Privacy Officer under HIPAA. He also has direct experience with GLBA, HIPAA, SOX (Sarbanes-Oxley), DoD DITSCAP, FDA Good Clinical Practice, FDA Electronic Records & Electronic Signatures (21CFR11), COPPA, FERPA, and is fluent in other many other regulatory environments.
Recently, he has been heavily involved in developing and refining compliance requirements for the non-traditional segments of the GLBA and HIPAA compliance communities, as well as SOX compliance. He is also extensive expertise in Dept. of Defense DITSCAP security regulatory requirements and certification, for both site and commercial products certifications. Of particular focus are regulatory harmonization compliance projects involving multiple overlapping regulatory schemas, such as: SOX + GLBA, HIPAA + GLBA, FERPA + HIPAA, FDA + HIPAA, etc.
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