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.

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Disadvantages of Spreadsheets – obstacles to compliance in the Healthcare Industry

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Spreadsheet woes – Burden in SOX Compliance and other Regulations

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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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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:

Uncover hidden opportunities with energy data analytics

What springs to mind when you hear the words energy data analytics? To me, I feel like energy data analytics is not my thing. Energy data analytics, however, is of great importance to any organisation or business that wants to run more efficiently, reduce costs, and increase productivity. Energy efficiency is one of the best ways to accomplish these goals.

Energy efficiency is not about investment in expensive equipment and internal reorganization. Enormous energy saving opportunities is hidden in already existing energy data. Given that nowadays, energy data can be recorded from almost any device, a lot of data is captured regularly and therefore a lot of data is readily available.

Organisations can use this data to convert their buildings’ operations from being a cost centre to a revenue centre through reduction of energy-related spending which has a significant impact on the profitability of many businesses. All this is possible through analysis and interpretation of data to predict future events with greater accuracy. Energy data analytics therefore is about using very detailed data for further analysis, and is as a consequence, a crucial aspect of any data-driven energy management plan.

The application of Data and IT could drive significant cost savings in company-owned buildings and vehicle fleets. Virtual energy audits can be performed by combining energy meter data with other basic data about a building e.g. location, to analyse and identify potential energy savings opportunities. Investment in energy dashboards can further enable companies to have an ongoing look at where energy is being consumed in their buildings, and thus predict ways to reduce usage, not to mention that energy data analytics unlock savings opportunities and help companies to understand their everyday practices and operating requirements in a much more comprehensive manner.

Using energy data analytics can enable an organisation to: determine discrepancies between baseline and actual energy data; benchmark and compare previous performance with actual energy usage. Energy data analytics also help businesses and organisations determine whether or not their Building Management System (BMS) is operating efficiently and hitting the targeted energy usage goals. They can then use this data to investigate areas for improvement or energy efficient upgrades. When energy data analytics are closely monitored, companies tend to operate more efficiently and with better control over relevant BMS data.