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FDA Regulated Companies & Health Care Practice
HIPAA Compliant Healthcare
Deploying electronic medical records (EMR) and other digital health technologies requires much more than just hardware and software. Making the transition to a digital workplace requires a high level of expertise in helping companies change the way their people do business with change management, process improvement, as well as the "as is" and "to be" process design and system requirements, and security.
HIPAA EMR / EHR Consulting
- HIPAA EDI standards compliance for payors and providers (4010 to 5010, transaction types 999, 997, 837, 835, 834, 820, 278, 277, 276, 271, 270 and others)
- ICD-9 to ICD-10 coding conversions
Click here to read more about 5010 and ICD-10 migration services
Payor Claims Systems
- Claims management & adjudication advisory
- Claims process modeling and process improvement
- Expertise in market leading claims systems software & solutions
Payor and Provider Process Improvement
We provide managers with proven quality solutions that balance the costs and risks of technology development while improving overall quality and competitiveness.
Medical Device Embedded Systems Development
The bioengineering professionals at our firm are experts in medical device development including requirements, interfacing with product planning, quality assurance, and product lifecycle development. We have seasoned professionals who have worked for some of the largest house hold names in the industry and have a proven track record of success.
Quality Management & Validation for Patient Safety
We bring world-class quality assurance methodologies, tools and facilities, experienced organizational advisory, and sophisticated risk assessment together to provide critical bottom line focused decision making ability. Our business process engineering professionals and methodology bring an end-to-end, top-to-bottom approach to managing a product’s quality. For information on our practice, click here.
FDA Adverse Event Reporting, Pharmacovigilance
Our firm has reference accounts in the FDA Regulated Space for Adverse Event reporting system, and quality management related to compliance. Our team has developed projects on time, and on budget for some of the largest public firms in the U.S. in their field. Business process engineering and modeling is key to reducing risk and designing requirements for new methods and technologies to aid in compliance. Our team has extensive experience with health care providers, health care payers, medical device firms, and pharmaceutical firms in these areas.
Sarbanes Oxley Consulting Practice
Gartner group states that the typical Sarbanes Audit is costing approximately $1 million per each $1 billion of revenue. No World Borders’s team members recently delivered the audit consulting services to a $5 billion plus public firm.
Our professionals have worked with one of the leading public accounting firms on SOX projects and understand their approach and methodology. We are experts in the alignment of regulatory frameworks such as COSO and COBIT with the economic realities of public large cap and mid-cap companies. For information on our practice, click here.
Service Oriented Architecture and Business Process Modeling
An agile enterprise, an organization’s ability to respond to or create change quickly and effectively, has many dimensions. The SOA Roadmap offering gives companies the ability to create an agile IT architecture. An agile IT architecture follows from five key principles:
- Portability—reuse of existing and new applications across business lines
- Platform independence—don’t lock yourself in
- Cross-platform interoperability—follow standards that take advantage of these principles
- Productivity—work in an environment that promotes rapid reuse of components and artifacts
- Scalability—be ready for what’s next
Six Sigma, ITIL, & Lean Techniques
According to the Six Sigma Academy, Black Belts save companies approximately $230,000 per project and can complete four to 6 projects per year. General Electric, one of the most successful companies implementing Six Sigma, has estimat ed benefits on the order of $10 billion during the first 5 years of implementation.
Enterprise and Industry Architecture, Governance
Our process improvement team uses a methodology that provides a framework called The Open Group Architecture Framework (TOGAF). It provides a comprehensive approach to the design, planning, implementation, and governance of an enterprise information architecture. The architecture is typically modeled at four levels or domains; Business, Application, Data, Technology. A set of foundation architectures are used to enable the architecture team to envision the current and future state of the architecture.
It provides a framework to help organizations:
- describe a method for defining an information system in terms of a set of building blocks
- show how the building blocks fit together
- use a set of tools to complete the architecture
- use a common vocabulary
- use recommended standards
- use a list of compliant products that can be employed to implement the building blocks
Easy to Use Consulting Services that Fit Your Company & Business Model
Services as easy to use as a staffing company combined with the service you expect from a major consulting firm with tenured professionals. Use No World Borders via three different methods:
- Staff augmentation: Contract us to augment your team as-needed.
- Retainer: Optimize your business by utilizing our highly skilled, staff longer term.
- Outsourced: Enable freedom to focus on your core competencies. No World Borders offshore team can provide properly structured projects with greater scale at a lower cost.
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