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HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

8/21/2013 - Biotechnology Compliance Covered Entities FDA HIPAA HITECH Manufacturers Medical Devices Pharmaceutical

Cybersecurity: FDA Risks for Medical Devices

On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. ...more

6/17/2013 - Cybersecurity DHS FDA HIPAA HITECH Medical Devices Software

Thoughts on Regulatory Constraints of Business Models

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

4/8/2013 - Business Development FDA Healthcare HIPAA HITECH Medical Devices Pharmaceutical Software Technology

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