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

amazon.co.uk

amazon.com

Check our similar posts

Failure Mode and Effects Analysis

Any business in the manufacturing industry would know that anything can happen in the development stages of the product. And while you can certainly learn from each of these failures and improve the process the next time around, doing so would entail a lot of time and money.
A widely-used procedure in operations management utilised to identify and analyse potential reliability problems while still in the early stages of production is the Failure Mode and Effects Analysis (FMEA).

FMEAs help us focus on and understand the impact of possible process or product risks.

The FMEA method for quality is based largely on the traditional practice of achieving product reliability through comprehensive testing and using techniques such as probabilistic reliability modelling. To give us a better understanding of the process, let’s break it down to its two basic components ? the failure mode and the effects analysis.

Failure mode is defined as the means by which something may fail. It essentially answers the question “What could go wrong?” Failure modes are the potential flaws in a process or product that could have an impact on the end user – the customer.

Effects analysis, on the other hand, is the process by which the consequences of these failures are studied.

With the two aspects taken together, the FMEA can help:

Discover the possible risks that can come with a product or process;
Plan out courses of action to counter these risks, particularly, those with the highest potential impact; and
Monitor the action plan results, with emphasis on how risk was reduced.

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

Is the GDPR Good or Bad News for Business

The European Union?s General Data Protection Act (GDPR) is a new data authority coming into force on 25 May 2018. It replaces the current Data Protection Directive 95/46/EC, while extending the remit to include the export of personal data outside the EU. It aims to give EU citizens and residents living there more control over their personal information. It also hopes to make regulatory compliance simpler for participating businesses.

The Broad Implications for Business
The GDPR puts another layer of accountability on businesses falling within its remit. It requires them to implement ?comprehensive but proportionate governance measures? including recording how they make decisions. The long-term goal is to reduce privacy infringements. In the short run, businesses without good governance may find themselves writing new policies and procedures.

Article 5 of the European Union?s General Data Protection Act lays down the following guidelines for managing personal data. This shall be ?
? Processed transparently, fairly, and lawfully
? Acquired for specific, legitimate purposes only
? Adequate, relevant and limited to essentials
? Not used for any other, incompatible purpose
? However it may be archived in the public interest
? Kept up to date with all inaccuracies corrected
? Ring-fenced when the information becomes irrelevant
? Adequately protected against unauthorised access
? Stored in a way that prevents accidental loss
Furthermore, affected businesses shall appoint a ?controller responsible for, and able to demonstrate, compliance with the principles.?

Implementing Accountability and Governance
The UK Information Commissioner?s Office has issued guidelines regarding provisions to assure governance and accountability. These are along the lines of the ?don’t tell me, show me? management approach the office has generally been following. In summary form, a business, and its controller must:
? Implement measures that assist it to ensure demonstrated compliance
? Maintain suitable, relevant records of personal data processing activities
? Appoint a dedicated data protection officer if scale makes this appropriate
? Implement technologies that ensure data protection by design
? Conduct data protection assessments and respond to results timeously

Implementing the General Data Protection Act in Ireland
The Irish Data Protection Commissioner has decided it is unnecessary to incorporate the GDPR into Irish law, since EU regulations have direct effect. The office of the Commissioner is working in tandem with data practitioners, and industry and professional bodies to raise awareness in business through 2017. It has produced a document detailing what it considers the essentials for business compliance. Briefly, these pre-requisites are:
? Ensure awareness among key personnel, and make sure they incorporate the GDPR into their planning
? Conduct an early assessment of quality management gaps, and budget for additional resources needed
? Do an audit of personal data held, to determine the origin, the necessity to hold it, and with whom shared
? Inform internal and external stakeholders of the current status, and your future plans to implement the GDPR
? Examine current procedures in the light of the new directive. Could you ?survive? a challenge from a data subject?
? Determine how you will process requests for access to the data in the future from within and outside your organization
? Assess how you currently obtain customer consent to store their data. Is this “freely given, specific, informed and unambiguous”?
? Find how you handle information from underage people. Do you have systems to verify ages and obtain guardian consent?
? Implement procedures to detect, investigate, and report data breaches to the Data Protection Commissioner within 72 hours
? Implement a culture of always assessing the effect on individual privacy before starting new initiatives

So Is the GDPR Good or Bad for Business
The GDPR should be good news for business customers. Their personal data will be more secure, and they should see their rate of spam marketing come down. The GDPR is also good news for businesses currently investing resources to protect their clients? interests. It could however, be bad news for businesses that have not been focussing on these matters. They may have a high mountain to climb to come in line with the GDPR.
Disclaimer: This article is for information only and not intended as a comprehensive guide.

Contact Us

(+353)(0)1-443-3807 (IRL)
(+44)(0)20-7193-9751 (UK)

Symbion Pharmacy Services? Definition of Responsibility

A ?symbion? is an organism in a symbiotic (i.e. mutually beneficial) relationship with another one. In the case of Australia?s giant Symbion Pharmacy Services, this means supplying and delivering over-counter Chemmart medicines to more than 3,000 hospital and retail pharmacies, while remaining mindful of its carbon footprint.

In 1999, the company with the tagline ?life matters? and a desire to be seen as ?a good corporate citizen? decided it was time to measure exactly what it was pumping out from 12 facilities and over 200 vehicles. This was a voluntary decision as even now there is still no carbon emissions law in Australia (although no doubt being a ?first mover? will put the company in a competitive position when this inevitably comes).

Symbion decided to install emission detection devices and connect these to a central monitoring system with the intention of managing what these measured. There were two stages to this process. First, Symbion determined its reporting requirements based on one of its larger warehouses. Following that, it established a carbon footprint for each of its wholly owned and managed facilities. This put it in a position to:

Analyse total emissions down to a level of detail where it understood the contribution of each source
Use big data management tools to identify carbon hotspots for priority remedial action
Inform the affected workforce, explain the monitoring system and keep them in the loop
Separately manage energy abatement programs such as lighting and delivery routes

The program also had productivity spin-offs in that it focused management attention on the processes behind the emissions that were ripe for material and system improvements. It also provided marketing leverage. Symbion?s customers are in the wellness business, ahead of the curve when it comes to how emissions contribute to chronic illness, and aware of the cost of this in terms of human capital.

EcoVaro could help you manage your throughputs by analysing your data on our cloud-based system. This includes trending your metrics, comparing them to your industry seasonal average, and providing you with a business-like view of how well you are doing.

Our service reduces your reliance on (and the cost of) third party audits, and simplifies the reporting process to your controlling authority. It simply makes more sense to contract your software out this way, and only pay for it when you need it.