Consider Design to Stay Competitive

HIPAA imposes a number of obligations on covered entities that have direct implications for device design.

Manufacturers may incur direct obligations to protect information.

The need to be competitive will force device makers to offer products that support a wide range of compliance policies and strategies––those who are able to do so early will enjoy a clear market advantage in large healthcare organizations.

Often, subtle technological issues are associated with adoption of policies. (For example, the loss of quick emergency access, incompatibility with evolving hardware or software, or increased downtime due to hindrance of effective maintenance or repair policies.)

Without appropriate policies and safeguards, sharing information securely and in compliance with HIPAA may be difficult. Facilitating the sharing of critical clinical trial data across institutions and over time, however, is an important capability.

Educating appropriate hospital staff on technical issues will prove valuable in introducing products and ensuring that they are used effectively.

Methods for providing electronic safeguards and accountability without introducing access problems or compatibility issues among devices or institutions will be critical.

The introduction of new, compliance-facile products will be complicated by the long service life of standard medical equipment.

Since the HIPAA regulations are expected to change over time, flexible solutions are necessary.

Because institutions are alert to the need for an effective compliance strategy, manufacturers that provide technical support for a range of options will enjoy competitive benefits.

Support of HIPAA compliance activities will require substantial efforts in instrument design and human systems engineering.