Main Subject - Business

Software as a Service (SaaS) is the new generation of ASP model designed to reduce the exorbitant costs of specialized medical practice management software. SaaS model is available for all aspects of medical practice management, including scheduling, billing, and electronic medical records (EM

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

R), which are mission-critical for high quality clinical service, business operations, and regulatory compliance. SaaS model extends the advantages of Application Service Provider (ASP) model, which in turn evolves from the traditional Client-Server model. This article briefly defines key con

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

epts and outlines a set of guidelines for SaaS vendor selection.

Client-Server (CS) Model

CS model involves central servers for database and application logic and multiple client modules connected to the central servers via local area network. This architecture allows allocation of

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

significant application logic on the client computer.

Applications architects considering CS model must weigh performance and security advantages against increased maintenance costs. CS benefits stem from local control of application logic and data. CS shortcomings too stem from localizing l

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

gic and data because local arrangement requires the user to take responsibility over application maintenance, including data security, redundancy, disaster recovery, upgrades, backups, etc.

The medical practice utilizing CS model must develop in-house expertise and manage numerous services, in

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

luding

Internet connectivity, bandwidth, and routers
Servers for Web server software, email, and firewalls
Database management
Data feed management
Capacity management
Redundancy management
Application upgrade management<

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

/li>

Financially, CS models require the software user to make significant upfront investment in hardware and licensing and justify the business case using ROI-based arguments, which make little sense because of software and hardware innovation pace.

Application Service Provider (AS

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

) Model

ASP model shields the medical practice from high cost of specialized software and data maintenance responsibilities but not from upfront investment in hardware and in software licenses. Early ASP applications were created from traditional CS applications by moving centralized dat

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

a and application servers to a third-party hosting service provider and allowing access to the application via HTML user interface as an afterthought. The third-party hosting service provider would take the responsibility for application maintenance and data protection.

The medical practice u

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ing early ASP model manages two costs:

Licensing and monthly support fee to software vendor
Software hosting fee to hosting vendor (typically a "pay-as-you-use model")

Software as a Service (SaaS) Model

SaaS model extends ASP benefits from outsourcing

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

of system maintenance to simplified financial responsibilities. SaaS vendors eliminate the upfront costs to medical practice by making the upfront investment in hardware and licensing on behalf of all medical practices using the application.

To make such a financial commitment, the hosting ve

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ndor must develop thorough expertise in application maintenance and new feature development. Such a requirement became feasible with recent technology progress in terms of security (128-bit SSL encryption) and browser-based client performance along with AJAX coding methodology. The new genera

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ion technology now compensates for earlier CS model deficiencies and justifies network-native SaaS software development by design.

Because of higher specialization, SaaS vendor is able to focus on client business requirements, resulting in more responsive service and higher client satisfaction

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

.

SaaS Vendor Selection

Medical practice in search of SaaS vendor must focus on the following topics:

Functionality: Does the application deliver all required functionality? Have you documented functional requirements subject to practice business goals, including

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

financial, practice workflow and personnel objectives? Have you considered integrated practice management functionality including patient scheduling, SOAP notes, and billing?

Training Plan: Will the vendor provide sufficient training? What drives the training process: pra

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

tice workflow changes or available software functionality?

Third-Party Application Interface: Does the application work with existing applications already deployed in the office? What data exchange requirements must be satisfied if you decide to purchase another application

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

later?

Performance: How do you measure application and service performance? Are formal performance metrics available continuously?

HIPAA Compliance: What controls are in place to enable access only on a "need to see" basis? Is every access instance l

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

gged using secure mechanism?

Service Level Agreement: What minimum service levels does the vendor guarantee to the client? What are the penalties for violating SLA?

Problem Resolution: Is there a formal process to communicate problem identification and

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

resolution? How is it tracked?

Data Access and Ownership: Who owns the data? Keep in mind that according to HIPAA, the patient is the ultimate owner of health data. How secure and private is the connection? Does it have Role based Access Control (RBAC)?

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

Disaster Recovery: How long would it take to recover from a disaster? Is a secondary data center available 24 x 7?

Disengagement Procedures: How long is data available upon severing the relationship? Who is responsible for data transfer to the new vendor?

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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