Valuing Private Certification

There are currently several private entities that seek to certify medical apps, connectivity solutions, EHR record exchange, and other products, services and people in our sphere of interest. Given the ongoing proliferation of private certifications, there is a growing need to evaluate them, judge their relative costs and benefits, and determine which – if any –  are worth adopting as either the one certified or as the consumer of certified products or services. These private activities are usually distinct from governmental requirements (e.g. FDA or FTC  compliance, or state licensing), although in the case of EHR Meaningful Use (MU) certification, private entities function on behalf of the federal government to certify compliant EHRs.  Note here that compliant EHRs are those that are capable of achieving MU. Purchasing a product that is thus certified is a prerequisite for a provider then achieving MU. Government/private interaction is also relevant to some Class II FDA device regulation which are eligible under third party review. Internationally, private  notified bodies are part of the CE process necessary to meet EU requirements. Private efforts can also become public when an authority having jurisdiction (AHJ) adopts or cites compliance with a non-governmental standard or certification as required by law or regulation. Private certifications can also have secondary private impacts such as when a third party requires compliance with a certification or sta...
Source: Medical Connectivity Consulting - Category: Technology Consultants Authors: Tags: Standards & Regulatory Source Type: blogs