I was analyzing the CFR21 part-11 standard for computerized system usage in clinical trials. CFR21 part 11 is modified to the following document.

The following are the base requirements of any software which needs to comply to the said standards. Please note that there is no software which can provide “Part11 compliant Software”. This is because part11 requires both procedural controls and administrative controls apart from technical controls to be in place. Hence the software can address the technology controls for the organization to assist being part of part11 compliance.

Analyzing the guideline document from the US Government department of health and human services, here are some of the features that the system should have to be part11 compliant.

• System should be configurable in terms of satisfying the requirements of the study protocol (For e.g. record data in metric units, blind the study)
• Data entry screens should have sufficient and configurable data validation framework to prevent errors in data creation, modification, maintenance, archiving, retrieval, or
  transmission
• Documented Standard Operating Procedures (SOP’s) to create, modify, maintain, or transmit electronic records, including when collecting source data at clinical trial sites
• The software should be able to churn out reports in various compliant format (XML, PDF etc) which should be able to report all entered data out in some form or another.
• System should have a capability to back-up data
• System should have authentication and authorization mechanism in place which allows only authorized individuals to view authorized information.
• Software system should have individual username/password for every individual accessing the system
• System should be able to capture all necessary audit trails data
• System dates and time should be correct and the change of dates should have controlled access in terms of changing the system properties
• Physical security at the location where the software system is hosted should also be ensured
• System should be able to reconstruct the source data
• Sufficient back-up and recovery procedures should be in place
• Disaster recovery framework should be in place and the data should be stored at remote location apart from the location where the primary system is executing
• Change control process should be in place. All changes should be documented and audited
• Training for the software should be conducted.

As part of this post, I will try to cover various healthcare standards and the various interesting links through out the web along these standards.

To that extent this blog is more of a weblog than a blog.

CFR-21 Part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

Wikipedia Link - http://en.wikipedia.org/wiki/Title_21_CFR_Part_11

US Gov Draft Document - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf

Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.

In May 2007, the FDA issued the final version of their guidance on computerized systems in clinical investigations. This guidance supersedes the guidance of the same name dated April 1999; and supplements the guidance for industry on Part 11, Electronic Records; Electronic Signatures — Scope and Application and the Agency’s international harmonization efforts when applying these guidance to source data generated at clinical study sites.

Effective use of Social Media for enterprises is becoming more and more impressive. A lot of enterprises are either evaluating or debating on how to effectively use social media for business benefits.

Being part of the healthcare IT space, I wanted to analyze the benefits of using social media in the healthcare sector. Here is a small list which I came up with and I would appreciate if it can be extended by the readers through experience and innovation.

Enterprise Twitter

Twitter has already taken the world by swing and enterprise twitter for healthcare is a very useful application in my opinion. Typically physicians and other healthcare professionals are always under strict timelines. Updating useful information on the move is a wonderful idea.

For e.g. If there is a patient visit re-scheduled the reception can alert the physician through a tweet immediately.

If there is an emergency and a set of individuals are to be intimated, twittering the message makes it a convenient option.

General awareness campaigns whenever required can be carried out easily through an enterprise twitter kind of platform.

Social Presence for Brand Building

Like every other enterprise, brand building is an important aspect in Healthcare as well. Having social presence will significantly improve brand building exercise for the institution. Institutions can market new services and solutions during social interactions. Focused awareness campaigns and informational sessions would further strengthen institutions brand.

Enterprise Social Network Platform

While external social network platform act as catalysts to improve brand building, healthcare institutions can significantly increase their patient relationship management and collaborations with different stake holders within and surrounding the healthcare set-up by maintaining their own enterprise social network set-up.

SaaS based PHR

With preventive care becoming more and more important with the patients, sharing personal health record information is becoming increasingly critical. The next generation Software as a service model can be leveraged to share patients personal health record information through secure web based interfaces.

Test Reporting over Mobile or Collaborative Platforms

Next generation mobile and collaborative platforms can be leveraged to transfer various medical reports to the patients. While patient physical presence might be required for some of the medical reports, there are a lot of such reports, whose information can be transmitted to the patient over mobile. Information transmission becomes easier and faster and at the same time it is convenient for both the healthcare institutions and patients.

I am sure there will be many more scenarios where social media and next generation Information technology solutions will be useful in the healthcare vertical. I would be pleased to get more inputs from others.

There really hasn’t been a tool to unify all the ways you can install Linux–until now.

The most common way to do network installations is network booting via PXE, which requires setup of a TFTP server and DHCP configuration. However, PXE is not viable in some situations due to external constraints–for instance, what if your department does not have control of your DHCP server? What if you are at home and don’t have a server of your own? Solutions for installing machines without PXE are useful in those cases. For virtualization technology like Xen and KVM, other fully automatic installation solutions are required.

Cobbler is a universal boot server that sets up everything you need for software installation–PXE, reinstalls, and virtualization. You can set up a Cobbler boot server for your favorite distros in just a few minutes. And as your provisioning needs grow, you can take advantage of more advanced features to further automate and simplify your systems administration requirements.

Got this jpg while browsing through Peepal through Amit’s mail. I found this pretty interesting

I was just working on getting an idea of the benefits an EMR system can bring to the healthcare unit. I came across the following EMR benefits which I may append as I get to learn more

EMR Benefits

Complete data: System-wide EMRs have greatly increased the amount of
patient information by populating the database with outpatient office visits
as well as inpatient hospital stays.

Information accuracy: Electronic data entry eliminates misinformation
from illegible handwriting on patient charts.

Safer treatment: Complete medical records, including at least a problem
list, allergies and medications, leads to safer treatment. Regular use of alerts
makes physicians more aware of safety issues about patient treatment.

Collaboration and consultation: EMRs allow multiple clinicians to organize,
configure and view patient data in multiple ways, which encourages collaboration
and consultation about diagnosis and treatment.

Real time availability: All events on a patient’s record are entered upon
transaction, collected in a single file, kept up-to-date and available immediately.
Previously, clinicians waited for paperwork to arrive or initiated treatment
with an incomplete file.

Speed and length of stay: Use of EMRs, especially in ERs, reduces treatment
time and improves patient outcomes. Quicker, more accurate and
safer medical treatment facilitated by an EMR has been proven to reduce
the length of inpatient stay by 10 percent or more.

Stress reduction: A beneficial side effect of relying on the EMR for patient
care is reduction among clinicians of the incidence of pressure ulcers stage
2 or more from 4.2 percent to 1.5 percent.

Adverse Drug Reaction Events : EMR helps reducing adverse drug events in the inpatient setting as well as ambulatory settings

Evidence Based Recommendations : EMR systems can integrate evidence-based recommendations for preventive services (such as screening exams)
with patient data (such as age, sex, and family history) to identify patients needing specific services.

Templates for Consistency : Condition-specific encounter templates implemented in an EMR system can ensure consistent recording of disease specific clinical results, leading to better clinical decisions and outcomes

Increased Compliance to Preventive Care : Reminders to patients generated by EMR systems have been shown to increase patients’ compliance with preventive
care recommendations when the reminders are merely interjected into traditional outpatient workflows

Electronic Messaging : Electronic messaging offers a low-cost, efficient means of distributing reminders to patients and responding to patients’ inquiries

Remote Monitoring Systems : Remote monitoring systems can transmit patients’ vital signs and other biodata directly from their homes to their providers,allowing nurse case managers to respond quickly to incipient problems

Elapsed time from medication orders to medication dispensing. The Stage 6 benchmarks in this area appear to be 15 to 20 minutes for routine orders, and less than 10 minutes for STATS.

Diagnostic report turn-around. The Stage 6 hospitals are reporting turnaround times in minutes instead of hours.

Medication errors. Stage 6 hospitals are finding more medication errors, but
are also able to show significant reductions in medication errors. In one case a
hospital has prevented 170 wrong patient errors; 1,500 wrong drug errors; 203
wrong dose errors; 2,947 wrong time errors; and 26 wrong route errors out of
158,684 administered doses. Another facility reports that 42 percent of errors
attributed to handwriting have been eliminated, and omitted drugs have been
reduced by 70 percent.

Reduction in agency nurses. Two facilities reported a reduction in the use
of agency nurses, and one facility does not currently use agency nurses. One
facility reports that approximately $2 million of agency nursing costs has been
eliminated at their facility.

Reduction in nursing overtime. Only one facility reports a reduction in nursing
overtime that has resulted in a $300,000 annual savings. Most of the Stage 6
hospitals report they have not seen any reduction in nursing overtime. One of
the facilities reported that since nurses are documenting at the bedside, the time
saved is being used for patient care. One organization reported that nursing
overtime is actually increased. It is apparent from the diversity of results that
regional and competitive environments will continue to produce varied results
on this subject

Length of Stay (LOS). The Stage 6 hospitals sharing metrics in this area had
either reduced their LOS metrics or maintained the same LOS metrics with
increasing census and acuity. HIMSS Analytics is conducting research on the
correlation of EMRAM stages/scores and LOS that is projected to be published
in September 2007. What we are finding to date is a reverse correlation – higher
EMRAM stages/scores have a reverse correlation to LOS (the higher the score
the lower the LOS).

Billing. This question was asked relative to the HIPAA Claims Attachment
regulations that will be effective within the next 24 to 36 months. Currently one
Stage 6 hospital reports a reduction in the time it takes to post both inpatient and
outpatient bills. Another hospital reports improvements in charge capture.

Claims Denials. Coding denials at one facility dropped from 9.2 to 2.2 percent
and overall denials dropped from 23 to 10 percent

Competitive market advantages. There were many responses given by Stage 6
hospitals in this area. Most of the responses were centered around patient safety
and clinician support to facilitate better patient care with aggressive marketing
of their EMR advantages to win patients via radio, TV, and Web/portal
marketing programs.

Hospital is an institution for health care providing patient treatment by specialised staff and equipment, and often but not always providing for longer-term patient stays. In terms of size hospitals can be compared to enterprises having various departments working cohesively to provide healthcare benefits to the patients. Hospitals have various departments based on the treating speacialities that the hospital provides. However apart from the treating speciality there are departments within the hospital which are pretty much common to all hospitals. Let us take a look at these departments within a hospital.

We can divide the departments within the hospitals in two major categories

• Administrative
• Clinical

Administrative

• Enterprise Management
• Resource Accounts
• Resource Manager
• Schedular

Patient Management

• Registration Manager
• OPD Admissions
• IPD Admissions
• Billing
• Managerial Accounting

Material Management

• Inventory
• Procurement
• Supplier Management

Care Management

• Diagnostics
• Therapy
• Clinical Notes
• Nursing
• Operation Theatre
• DICOM - PACS

Support Services

• Pharmacy
• Blood Bank
• HR Management
• Health Promotion
• Kitchen & Laundry

Communication

• Internal Communication
• Payer Communication
• Supplier Communication

ReportIT

• Standard Reports
• Custom Reports
• Report Designer

Accounting and Costing

• Financial Accounting
• Advance Accounting
• Costing Analysis

Data Analytics

• Business Intelligence.

Clinical

• Laboratory.
• Radiology.
• PACS.
• Telemedicine.
• Critical Care.
• Paediatric Care.
• CSSD Management
• Clinical Support and Personal Health Record
• Dental Care
• Perioperative Care
• Nursing Care

Wikipedia’s definition of Hospital Information Systems

“A hospital information system (HIS), variously also called clinical information system (CIS) is a comprehensive, integrated information system designed to manage the administrative, financial and clinical aspects of a hospital. This encompasses paper-based information processing as well as data processing machines.”

A beg to differ.

There are essentially two major activity segments in which a typical hospital is divided

-Hospital Administration
-Clinical Care Management

Hospial Administration typically includes administrative, financial, day-to-day activities, patients in-bound and out-bound traffic, scheduling, billing and all the other activities.

Clinical Care Management typically includes everything to do with patient’s clinical activities to Interacting with other entities involved in Patient care. This includes Patient encounters, patients medical history records, patient surgeries, medical prescription, pharmacy Integration, Laboratory Integration, Medical equipment interfacing and much more.

Hence clubbing Clinical care management and hospital administration in my opinion is not a good idea.

Hospital administration activities are more of the surrounding activities which revolves more importantly around the financial aspects of the hospital, whereas Clinical management deals with Patient care and safety.

Majority of the Information technology today hits the first section within the hospitals and provide really intutive and easy to use hospital management/information systems. This solutions will have ability to register patients, schedule patients, print bills, manage hospital finances, manage inventories, manage laundries, resource planning and other business functions.

Clinical Information Systems also called “CIS” is an Information technology solution which will be use to increase efficiency in the neglected area of Clinical Management systems. CIS should provide ways and means to improve Quality of clinical care. There is one more general synonym for CIS widespread in the market and this is known as “EMR”. And I must admit this is much closer to CIS than HIS, although not exactly the same. EMR stands for Electronic Medical Record. This is the patient’s medical record which is stored electonically. The entire patient’s medical history is captured electronically in the medical record. However EMR is one part and rather an important part of Clinical Information System. However CIS is much more than just EMR. CIS is targetted to integrate all the clinical activities inside a healthcare unit so that there is seamless interaction between all the eligible clinical systems to attain total patient safety. So along with EMR, one would also have an integrated laboratory, integration pharmacy, integrated nursing,integrated equipments. CIS systems also provide decision support tools to make clinicians better medical decisions based on gathered historical data. They also have clinical alerts capabilities which will allow required timely updates.

To conclude, Clinical Information Sytems are much more than Hospital Information systems or Electronic Medical Records. Clinical Information Systems are built to enchance the overall Clinical Information Workflow rather than just capturing the Patient’s data electronically or increasing hospital administration efficiences.

Health care, or healthcare, refers to the treatment and management of illness, and the preservation of health through services offered by the medical, pharmaceutical, dental, clinical laboratory sciences (in vitro diagnostics), nursing, and allied health professions. Health care embraces all the goods and services designed to promote health, including “preventive, curative and palliative interventions, whether directed to individuals or to populations”.

Healthcare in India is the responsibility of constituent Indian states.The National Health Policy was endorsed by the Parliament of India in 1983 and updated in 2002.

Indian Healthcare Issues

Malnutrition

• Half of children in India are underweight, one of the highest rates in the world and nearly double the rate of Sub-Saharan Africa.
• India contributes to about 5.6 million child deaths every year, more than half the world’s total.

Women and Children

• India contributes to about 5.6 million child deaths every year, more than half the world’s total
• The maternal mortality in India is the second highest in the world.Only 42% of births in the country are supervised by health professionals
• According to UNDP Human Development Report (1997), 88% of pregnant women (age 15-49) were found to be suffering from anemia.

Water and Sanitation

• In 2002 by the World Health Organisation that around 700,000 Indians die each year from diarrhoea.
• As of 2003, it was estimated that only 30% of India’s wastewater was being treated, with the remainder flowing into rivers or groundwater.

Healthcare Infrastructure

• India spends relatively little on healthcare, which accounts for 4.8 per cent of India’s GDP. Of this, 3.6 per cent is contributed by the private sector and only the balance 1.2 per cent by the Government
• Further, a recent WHO report indicates that India spends just 17 per cent of its public expenditure on health while the corresponding percentages for Pakistan, Bangladesh, China and Brazil are 20, 28, 38 and 54, respectively
• As per analysis the current (2006) bed per thousand population ratio for India stands at 1.03 as against an average 4.3 of comparable countries like China, Korea and Thailand (2002 data).
• Out of the total about 896,500 beds will be added by the private sector with a total investment of 69.7 Billion US$ (Rs 222,000 Crores) over the next six years
• However, the gains are commensurate in this capital intensive industry, since the revenues generated by private hospitals in the year 2012 will be to the tune of US$ 35.9 Billion (Rs. 161,440 Crores) growing at a CAGR of 15%.
• Shortfall of over 450,000 doctors in the year 2012 is foreseen.
• India would require investments of up to $20 billion over the next 5 years
• A middle-level manager with a family of four, spends between US $ 170 and US $ 255 a year on healthcare – compared to just US $ 43 in the late –1980s

References :

• http://www.ibef.org/artdisplay.aspx?cat_id=391&art_id=5204
• http://www.thehindubusinessline.com/2008/08/22/stories/2008082250140800.htm
• http://www.ficci.com/media-room/speeches-presentations/2007/jan07/ExecutiveSummaryReport.pdf
• http://en.wikipedia.org/wiki/Healthcare_in_India#Issues

I got this idea while I was on my way to office today and thought to write it down before it wipes of my RAM.

India has a significant contributions to IT services. However when it comes to Software product Development we need to still prove our mettle.I am sure a lot of discussion must have already gone into this topic and is still happening. Here are my thoughts on the same.

Everybody knows that there is a significant difference in the way an IT services company is executed and a product development organization. However what is happening is since majority of the Indian IT professionals have a services mindset, they unconsiously tend to bend towards executing a product development company also on lines of a services company.

One needs to understand that the gestation period of a product is always much more than an services. The time it takes to build a steady product is significantly higher than developing a piece of customized software for a client.  Hence it is essential to plan the gestation journey to start with meticulosly. This is the first hurdle that one needs to pass.

Another important aspect to understand is that the product always goes to various iterative cycles over the time to improve. As against customized software which will not vary much unless doing further enhancements whenever required. Product instead
will get refined increasing its footprint, defining more features and so on. Apart from engineering, marketing and sales of a product is totally different than what happens in a services domain. India in my opinion needs to significantly improve in this area if they need to build successful products. I am sure Indian talent is capable of developing world class products (For that matter many of the world class products are engineered in India, although they are for global companies). The need is to understand the other areas which are required for a product company which are totally different than the services organization.

Here, I would wish to move towards Indian Manufacturing or India pharma. If you observe over the years, once India started opening up, Indian manufacturers have indeed shown the world that they can create world class products can necessarily also execute world class organizations.Manufacturing or pharma were tradionally into product making and not services. Hence they have mastered the art of product making.

Firstly, they focus on the very minute details of engineering before building things. The concept of a very detailed design is quite clearly visible in manufacturing while it is lacking to an extent in software product.

The plan for profitability is again laid out considering all the factors in quite details. The risk taking appetite is much more and the margins are calculated very carefully. One of the advantage that IT comapnies had over the years was the margins due to export. Most of the IT services companies worked for clients outside India and hence they are used to deduce huge margins owning to currency difference. This IMO,does not allow them to take significant risks. They always want to break-even as early as they engineer a product.

I think the Indian software product development, needs to follow Indian manufacturing in terms of risk apetite, planning and finer level execution to be globally successful in terms of product development and needs to change the services mentality.