The Connected Health Practice at The Anson Group has been designed to complement and extend our deep experience with medical technology regulatory requirements to the converging world of life sciences, healthcare delivery, and information and communication technologies, as they connect through a common network based on the Internet. 

This new environment, to which Anson refers in broad terms as Connected Health, is creating new opportunities and challenges for existing manufacturers of life science products, who wish to leverage the power of the Internet:  pervasive mobile and wireless access to information, interoperable electronic health records, and large-scale data analysis capabilities.

• Track and improve patient adherence
• Increase the value of products for patient treatment by connecting them with other resources
• Move towards personalized, targeted treatment and prevention
• Monitor adverse events and improve product surveillance
• Identify and recruit patients for participation in clinical studies
• Gain better insight into the performance of products
• Use data analysis to bridge the gap between research and positive patient outcomes
• Build stronger, more valuable relationships with healthcare providers and patients
• Take advantage of outside resources through networked innovation research and development
• Collaborate electronically with business partners
• Enable the business model to shift away from a transactional model to outcomes-based payments
• Convergence of biological, physical, and engineering sciences
• Enabling personalized medicine through genomics, biomarkers, and imaging technologies
• Convergence of diagnostics and therapeutics
• Convergence of clinical engineering, informatics, and information technology (IT)
• Interoperability of research and clinical information systems
• Mobile and wireless access of health information through smart phones and tablet computers
• Consumerization of IT
• Development of remote monitoring, data capture, and data analysis technologies
• Development of sensors, body area networks, and personal area networks
• Machine-to-Machine (M2M) communications
• Development of cloud computing and virtualization of traditional IT systems
• Development of big data and real time analytics
• Development of nanoscale technology
• Development of social media technologies
• Interoperability of medical devices and health information technology
• Interoperable networked medical devices

 

• Convergence of biological, physical, and engineering sciences
• Enabling personalized medicine through genomics, biomarkers, and imaging technologies
• Convergence of diagnostics and therapeutics
• Convergence of clinical engineering, informatics, and information technology (IT)
• Interoperability of research and clinical information systems
• Mobile and wireless access of health information through smart phones and tablet computers
• Consumerization of IT
• Development of remote monitoring, data capture, and data analysis technologies
• Development of sensors, body area networks, and personal area networks
• Machine-to-Machine (M2M) communications
• Development of cloud computing and virtualization of traditional IT systems
• Development of big data and real time analytics
• Development of nanoscale technology
• Development of social media technologies
• Interoperability of medical devices and health information technology
• Interoperable networked medical devices

 

While Connected Health as a whole is concerned with the overall impact of networked communication and information technologies on the complete healthcare ecosystem, aspects of the Connected Health can be separated to help companies focus and prioritize strategies for adoption and adaptation to a future of completely digitized healthcare. 

Category	Primary Attribute	Status
Health Information Technology (HIT)	Interoperable and secure electronic medical records Research Bioinformatics Computing and Clinical Patient Systems Interoperability	Still in development Investments made through funding from HITECH Meaningful Use Incentives legislation
Interoperable Medical Devices	Interoperability between medical devices and clinical systems in HIT acute care settings. Patient and treatment protocol awareness	Developing technology standards to support direct network connectivity between medical devices IEC 80000-1 Management Framework
Mobile Health Technologies	Ambulatory remote monitoring and care delivery through medical technology deployed in the patient’s home or through mobile network access	Rapidly evolving, being built on existing base of technologies for home broadband and cell phone connectivity

Anson Group can provide advice and assistance in developing and maintaining regulatory compliant strategies and in adoption of connected health technologies through our unique blend of skills and experiences from our multi-disciplined team of consultants who include:

• Regulatory Scientists
• Regulatory Affairs Professionals
• Quality Systems Specialists
• Clinical Scientists
• Information Technologists
• Specialists in Product Development, Product Engineering, and Regulated Software

Anson supports:

• Regulatory Strategy
• Education and training on important connected health standards and regulations from HHS, FDA, FCC, and ONC
• Impact assessments of Connected Health technology on the Regulated Industry
• Product and system architecture consulting to comply with FDA requirements
• Product submissions services that include Connected Health components