Disadvantages of Spreadsheets – Obstacles to Compliance in the Healthcare Industry

Most of the regulatory compliance issues we talked about concerning spreadsheets have been related to financial data. But there are other kinds of data that are stored in spreadsheets which may also cause regulatory problems in the future.

In the US, a legislation known as HIPAA or Health Insurance Portability and Accountability Act is changing the way health care establishments and practitioners handle patient records. The HIPAA Privacy Rule is aimed at protecting the privacy of individually identifiable health information a.k.a. protected health information (PHI).

Examples of PHI include common identifiers like a patient’s name, address, Social Security Number, and so on, which can be used to identify the patient. HIPAA covers a wide range of health care organisations and service providers, including: health plan payers, health care clearing houses, hospitals, doctors, dentists, etc.

To protect the confidentiality, integrity, and availability of PHI, covered entities are required to implement technical policies such as access controls, authentication, and audit controls. These can easily be implemented on server-based systems.

Sad to say, many health care organisations who have started storing data electronically still rely on spreadsheet-based systems. Those policies are hard to implement in spreadsheet-based systems, where files are handled by end-users who are overloaded with their main line of work (i.e. health care) and have very little concern for data security.

In some of these systems, spreadsheet files containing PHI may have multiple versions in different workstations. Chances are, none of these files have any access control or user authentication mechanism whatsoever. Thus, changes can easily be made without proper documentation as to who carried out the changes.

And because the files are normally easily accessible, unauthorised disclosures – whether done intentionally or accidentally – will always be a lingering threat. Remember that HIPAA covered entities who are caught disclosing PHI can be fined from $50,000 up to $500,000 plus jail time.

But that’s not all. Through the HITECH Act of 2009, business associates of covered entities will now have to comply with HIPAA standards as well. Business associates are those companies who are performing functions and services for covered entities.

Examples of business associates are accounting firms, law firms, consultants, and so on. They automatically need to comply with the standards the moment they too deal with PHI.

 

More Spreadsheet Blogs

 

Spreadsheet Risks in Banks

 

Top 10 Disadvantages of Spreadsheets

 

Disadvantages of Spreadsheets – obstacles to compliance in the Healthcare Industry

 

How Internal Auditors can win the War against Spreadsheet Fraud

 

Spreadsheet Reporting – No Room in your company in an age of Business Intelligence

 

Still looking for a Way to Consolidate Excel Spreadsheets?

 

Disadvantages of Spreadsheets

 

Spreadsheet woes – ill equipped for an Agile Business Environment

 

Spreadsheet Fraud

 

Spreadsheet Woes – Limited features for easy adoption of a control framework

 

Spreadsheet woes – Burden in SOX Compliance and other Regulations

 

Spreadsheet Risk Issues

 

Server Application Solutions – Don’t let Spreadsheets hold your Business back

 

Why Spreadsheets can send the pillars of Solvency II crashing down

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How SOA can help Transformation

Undoubtedly, today’s business leaders face myriad challenges ranging from fierce market competition to increasing market unpredictability. In addition, the modern consumer is more informed and in control of what, where and how they purchase. Couple these challenges with effects of globalization, and you will appreciate that need for business transformation is more of a necessity than a privilege.

As recent business trends show, top companies are characterized by organizational and operational agility. Instead of being shaken by rapid technological changes and aftershocks associated with market changes, they are actually invigorated by these trends. In order to survive in these turbulent times, business leaders are opting to implement corporate transformation initiatives to develop leaner, more agile and productive operations. In line with this, service oriented architecture (SOA) has emerged as an essential IT transformation approach for implementing sustainable business agility.

By definition, service oriented architecture is a set of principles and techniques for developing and designing software in form of business functionalities. SOA allows users to compile together large parts of functionality to create ad hoc service software entirely from the template software. This is why it is preferred by CIOs that are looking to develop business agility. It breaks down business operations into functional components (referred to as services) that can be easily and economically merged and reused in applicable scenarios to meet evolving business needs. This enhances overall efficiency, and improves organizational interconnectivity.

SOA identifies shortcomings of traditional IT transformation approaches that were framed in monolithic and vertical silos all dependent on isolated business units. The current business environment requires that individual business units should be capable of supporting multiple types of users, multiple communication channels and multiple lines of business. In addition, it has to be flexible enough to adapt to changing market needs. In case one is running a global business enterprise, SOA-enabled business transformation can assist in achieving sustainable agility and productivity through a globally integrated IT platform. SOA realizes its IT and business benefits by adopting a design and analyzing methodology when developing services. In this sense a service consists of an independent business unit of functionality that is only available through a defined interface. Services can either be in the form of nano-enterprises or mega-enterprises.

Furthermore, with SOA an organization can adopt a holistic approach to solve a problem. This is because the business has more control over its functions. SOA frees the organization from constraints attributed to having a rigid single use application that is intricately meshed into a fragmented information technology infrastructure. Companies that have adopted service oriented architecture as their IT transformation approach, can easily repurpose, reorganize and rescale services on demand in order to develop new business processes that are adaptable to changes in the business environment. In addition, it enables companies to upgrade and enhance their existing systems without incurring huge costs associated with ‘rip and replace’ IT projects.

In summary, SOA can be termed as the cornerstone of modern IT transformation initiatives. If properly implemented great benefits and a sharp competitive advantage can be achieved. SOA assists in transforming existing disparate and unconnected processes and applications into reusable services; creating an avenue where services can be rapidly reassembled and developed to support market changes.

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ISO Certification and Training

Overview

ISO, or the International Organisation for Standardisation, is a global standard-setting body, made up of a network of various standards organisations from among its 162 member-nations. ISO is a vital force in the manufacturing industry, promoting industrial and commercial global standards for specifications and requirements in materials, products, procedures, information, and quality management.

ISO Certification

For a company, an ISO Certification:

? Is an assurance that the organisation, has met the required management of processes and documentation.

? Provides standards on how businesses and organisations manage information and processes;

? Does not impose any regulations;

? Is not like a license that allows a business or company to operate.

Rather, an ISO Certification merely certifies that a management system, a manufacturing process, or an offered service has all the elements for quality assurance and the capability to compete in the international market.

That said however, an ISO Certification is still vital to most businesses because it brings them up to par with global standards. For instance, in many industries, contracting companies are required ISO 9001 certification, and some government contracts, such as in the oil industry or medical technologies, depend largely on ISO 9001 compliance. Most ISO Standards are specific to different industries, processes, and products, but ISO 9001 is a management system standard that can be applied to any company.

ISO 9001

ISO 9001 is unarguably, one of the most established Quality Management Systems program in the world today that can be a useful tool for any organisation. ISO 9001 Standards is currently the recognised standard not only for quality management systems, but management systems in general, ensuring quality in all aspects ? products, services, and documentation.

Any company, regardless of size or sector, aiming to improve its operations and management, would do well with an ISO 9001 Certification, especially if the organisation is prepared to implement the standards throughout the entire organisation and not just in particular departments or divisions.

Find out more about our Quality Assurance services in the following pages:

Total Quality Management

Failure Mode and Effects Analysis

Six Sigma

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What GDPR Means in Practice for Irish Business

The General Data Protection Regulation (GDPR) is a European directive aimed at ring-fencing consumer data against illegal or unnecessary access. There is nothing to discuss or debate with local politicians, or the Irish Data Protection Commissioner for that matter. As a European directive, it has over-riding power. To obtain an English version, please visit this link, and select ?EN? from the table of languages.

As you reach for your tea, coffee or Guinness after sighting it, you will be glad to know the Irish Data Protection Commissioner has the lead in turning this into business English we understand. The following diagram should assist you to obtain a quick overview of the process we all have to go through. In this article, we briefly describe what is inside Boxes 1 to 12. The regulation comes into force on 25 May 2018 so we have less than a year to get ready.

The 12 Essential Steps to Implementing the General Data Protection Act

1. Create awareness among your people of what is coming their way. The GDPR has given our regulator discretion to dish out fines up to ?20,000,000 (or 4% of total annual global turnover, whichever is greater) so there is determination to make this happen.

2. Become accountable by understanding the consumer data you hold. Why are you retaining it, how did you obtain it, and why did you originally collect it. Now you know it is there, how much longer will you still need it? How secure is it in your hands, have you ever shared it?

3. Open a communication channel with your staff, your customers, and anyone else using the data. Share how you feel about how accountable you have been with the information in the past. Explain how you plan to comply with the GDPR in future, and what needs to change.

4. Understand the personal privacy entitlement of the subjects of the information. They have rights to access it, correct mistakes, remove information, restrict its use, decline direct marketing, and copy it to their own files. What needs to change in your systems to assure these rights?

5. Issue a policy for allowing consumers access to their information you hold. You must process requests within a month, and you may not charge for the service unless your cost is excessive. You may decline unfounded or excessive demands within your policy guidelines.

6. Adapt to the requirement that you must have a legal basis for everything you do with, and to consumer data. You need to be in a position to justify your actions to the Irish Data Protection Commissioner in the event of a complaint. Having a legitimate interest is no longer sufficient.

7. Ensure that consumer consent to collect, use, and distribute their data is ?freely given, specific, informed, and unambiguous.? From 25 May 2018 onward, this consent will be your only ground to do so. You cannot force consent. Your benchmark becomes what the GDPR says.

8. Issue rules for managing data of underage subjects. This is currently under review and we are awaiting results. Put systems in place to verify age. Set triggers for where guardians must give consent. Make sure age is verifiable. Use language young people understand.

9. Introduce a culture of openness and honesty, whereby breaches of the GDPR are detected, reported, investigated, and resolved. You will have a duty to file a GDPR report with the Data Protection Commissioner within 72 hours, thus it is important to fast track the process.

10. Introduce a policy of conducting a privacy assessment before taking new initiatives. The GDPR calls for ?privacy by deign?, and we need to engineer it in. This may be the right time to appoint a data controller in your company, and start implementing the GDPR while you have time.

11. You may also need to appoint a data protection officer depending on the size of your business. Alternatively, you need to add managing data protection compliance to an employee?s duties, or appoint an external data-protection compliance consultant.

12. Finally, and you will be glad to know this is the end of the list, the GDPR has an international flavour in that multinational organisations will report into the EU Lead Supervisory Authority. This will manage the process centrally while consulting national data authorities.

The GDPR is a project we all need to complete. If we are out of line, it is in our interests to get things straightened out. Once everything is in place, the task should not be too onerous. Getting there could be the pain.

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