How to improve your SRS by distinguishing between vague and ambiguous requirements in health IT and medical device systems

Because it’s so easy to build software these days we’re seeing a proliferation of healthcare apps — what’s hard to figure out is whether we’re building the right software. Abder-Rahman Ali, currently pursuing his Medical Image Analysis Ph.D. in France, has graciously agreed to give us advice on how to write good software specifications for health and medical technology solutions. Some of you are probably rolling your eyes and thinking that software requirements specifications (SRS) are old and “tired” and we should be writing agile user stories instead.

Patient engagement is something that physicians have done for thousands of years as they cared for patients (whether going to their homes or having them come to hospitals or clinics). With new digital health technologies the way providers can engage with patients is changing significantly but we’re not quite sure about the best ways to apply that technology. This is why I’m looking forward to attending MedCityNews.com’s ENGAGE conference next week in Washington, DC.

The Fred Alger Management team reached out to me recently asking what innovative changes I thought the medical and healthcare industry will be going through over the next 50 years. It was for their innovative “Think Further” series: [youtube=https://www.youtube.com/watch?v=iOgt85cPU8Q&list=UUcpr1hudOhiPOsj-7rwe8Ew&w=520] As Yogi Berra famously quipped “It’s tough to make predictions, especially about the future” but Alger’s “Future of Medicine” question is an interesting approach to generating ideas so I thought I’d give it a shot.

Cambridge HealthTech Institute (CHI) invited me to attend their Next Generation Point of Care Diagnostics Conference and I came away thoroughly impressed with the content, speakers, and organization. Since I chair several conferences a year I know how hard it is to pull off a good one so I’d like to thank CHI for a job well done. Goals & Attendees The goal of the event was to provide a progress update to the healthcare industry on the advances in next generation point-of-care (POC) diagnostics while highlighting the advent of innovative platforms and use of digital information systems to aid in the development of novel POC diagnostics.

Given the number of breaches we’ve seen this Summer at healthcare institutions, I’ve just spent a ton of time recently on several engineering engagements looking at “HIPAA compliant” encryption (HIPAA compliance is in quotes since it’s generally meaningless). Since I’ve heard a number of developers say “we’re HIPAA compliant because we encrypt our data” I wanted to take a moment to unbundle that statement and make sure we all understand what that means.

These days it’s pretty easy to build almost any kind of software you can imagine — what’s really hard, though, is figuring out what to build. As I work on complex software systems in government, medical devices, healthcare IT, and biomedical IT I find that tackling vague requirements is one of the most pervasive and difficult problems to solve. Even the most experienced developers have a hard time building something that has not been defined well for them; a disciplined software requirements engineering approach is necessary, especially in safety critical systems.

Our vision of providing a series of packed one day events focused on practical, relevant, and actionable health IT advice were very well received in Houston, NYC, and Santa Monica earlier this year. Our next event is in Chicago and we’re going to continue to eschew canned PowerPoint decks which limit conversations and instead deliver on the implications of major trends and operationalizable advice about where to successfully apply IT in healthcare settings.

I’ve been looking at hospital supply chain automation and the IT surrounding it for a number of years now. Starting with Cardinal Health but then moving on to help a number of other vendors in the space, I’ve felt that there’s not been enough next-generation tech being applied to the low margin, high volume business of hospital supply management. Hospitals often spend tens of millions of dollars on EHRs and other IT systems that have little direct cost reduction capability but they ignore, often at their peril, supply management systems that can save immediate dollars.

I’ve been getting many questions these days about big data tools and solutions, especially their role in healthcare analytics. I think that unless you’re doing large scale analysis of biomedical data such as genomics, it’s probably best to stick with traditional tried and true analytics tools. Online Analytics Processing (OLAP) can be invaluable for medical facilities to use when interpreting data and health informatics because most of that data is in relational, key-value, or hiearchical databases (such as MUMPS).

Melissa McCormack, a medical researcher with EHR consultancy group Software Advice, recently published their medical practice management BuyerView research, which found that 63% of the buyers were replacing existing PM solutions, rather than making a first-time purchase. This mirrors the trend we’ve seen across medical software purchasing, where the HITECH Act may have prompted hasty first purchases of EHR solutions, followed by replacements 1-2 years later. For PM vendors, this means there’s a huge opportunity to market your products to practices as an upgrade, even if they’re already using PM software.

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