91–100 of 159 posts
Earlier quoted context omitted.
They are largely one and the same; because as soon as you start claiming your product or service can improve a user's health, you're subject to the regulatory scope of the FDA. I mean, you can claim that things like MyFitnessPal are health apps, but it's still a fine line you have to walk where you can't give any advice, all you can do is observe and report. Try to go any further than that and you're providing diagno…
Inspections and licensing of restaurants and grocery stores are typically handled by local and county health departments. (Not the FDA) http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194244.ht... Though, yeah, given that the FDA is the FOOD and Drug Administration , I am sure they impact grocery stores: https://foodpoisoningbulletin.com/2014/fda-proposes-rule-for... That does not mean HIPAA impacts grocery stores…
What you describe is absolutely the wrong way to start a business: you should look at the type of business you want to open (in this case, a restaurant) and look for white spaces. Opening an organic restaurant is only a sensible idea if the market would respond to an organic restaurant and the category isn't already over-served. If that overlaps with your passion, then great!
Never mind there is no scientific evidence saying organic food is better for you - this is where "health" delves into pseudoscience, and the entire reason the FDA exists.
Having done exactly this type of integration with legacy systems I think a point that gets glossed over is that it's the startups themselves who are full of engineers who think that the whole world has moved on to using NoSQL Node.js RESTful JSON APIs in the cloud (that buzzword soup was intentional) when the reality is that the majority of established businesses are using unsexy and what they would consider to be "l…
I once asked a question online about a legacy technology. The only answer I got was a smug "don't use [technology], it's outdated."
I work in a "people's lives depend on this" industry, not a "move quick and break things" industry. That's why I am working with "outdated" technology.
We could have spent hundred of millions of dollar and several years to rewrite the system I was working on to use the latest technology stack. But for what? It works and does its job well.
Earlier quoted context omitted.
Inspections and licensing of restaurants and grocery stores are typically handled by local and county health departments. (Not the FDA) http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194244.ht... Though, yeah, given that the FDA is the FOOD and Drug Administration , I am sure they impact grocery stores: https://foodpoisoningbulletin.com/2014/fda-proposes-rule-for... That does not mean HIPAA impacts grocery stores…
Well that's because a grocery store isn't a health care company: it's a retailer. You can also buy very unhealthy things at the grocery store. What you describe is absolutely the wrong way to start a business: you should look at the type of business you want to open (in this case, a restaurant) and look for white spaces. Opening an organic restaurant is only a sensible idea if the market would respond to an organic r…
It seems to me that what I am describing is exactly what (at least some) disruptive businesses -- like AirBnB -- do: Redefine the problem in order to find a white space because the thing they are doing did not exist until they did it, so there isn't really any competition.
I'm in the Health IT space but we took a different approach. Early on we realized most Health IT companies are really pharmaceuticals but they don't realize it. What I mean by this is, you need to have the budget of a pharmaceutical to play in this space: 1 - you need to spend millions to win over consumers and 2 - you need to have an existing network of connections into doctor's offices to convince them of your solu…
This comment and the OP mirror my own experience(s). Additionally, data interchange between competitors is a non-starter. Possible solutions (work-arounds) will be single payer or continued market consolidation (hospitals merging and then implementing one of the big systems like EPIC). Not mentioned is that continued churn like HL7 v3, ICD-10, meaningful use, etc. are hugely onerous while adding zero value. A cynic m…
Agree completely on the IT & product integration barriers highlighted in the article. This (& more) make health care a nuanced place to build a business.
There are simply more stakeholders to manage:
- Employers (Google, etc; those w/ >500 emps usually carry financial health care risk)
- Plans (United, etc; both carry risk and administer employer plans)
- Providers (Sutter, etc; deliver care, can carry some risk, contract with plans, and sometimes contract directly w/ employers)
- Benefits Consultants (Mercer, etc; guide employers, more)
- Societies (AMA, etc; build guidelines, unify provider voices, more)
- Patients (you; remain frustrated w/ system complexity)
- Consolidators (McKesson (Rx logistics & channel), Express-scripts (pharmacy benefit manager); add leverage and efficiency)
- Regulators (HHS (HIPAA), FTC, FDA, etc; define ground rules for all these players)
- Suppliers (Pharma, device, digital health; sell value into this space)
But it’s also very, very fascinating. And once you suffer through some of the learning curves can get quite fun. There are enormous financial and impact opportunities to be had. The wall can be a little high.
I'm always still learning, but if you need help on your idea and how it'd fit in, email me at sean@omadahealth.com.
Saying these companies could just open their APIs is probably wrong. None of the legacy EMRs has a good underlying data model and what they have tends to be customized per site. There might be some minor functionality you could get to work consistently across sites with such an open API but chances are it wouldn't cover everything your innovative startup needs. In summary I don't think it's only lack of willingness;…
What you say is true. I solved the problem by flipping it around. I'm going to give away the secret sauce I created for our backend. "Traditional" EMRs imagine an idealized data model and then write ETLs to import to that model. The jargon we used was "adjudicating the single best record (SBR)" or "source of truth". My system slurped up all data, stored mostly as-is, and then used information retrieval strategies (th…
I’m in the digital health space (CEO of Omada Health). Agree completely on the IT & product integration barriers highlighted in the article. This (& more) make health care a nuanced place to build a business. There are simply more stakeholders to manage: - Employers (Google, etc; those w/ >500 emps usually carry financial health care risk) - Plans (United, etc; both carry risk and administer employer plans) - Provide…
I'm in the Health IT space but we took a different approach. Early on we realized most Health IT companies are really pharmaceuticals but they don't realize it. What I mean by this is, you need to have the budget of a pharmaceutical to play in this space: 1 - you need to spend millions to win over consumers and 2 - you need to have an existing network of connections into doctor's offices to convince them of your solu…
EHRs are starting to open up more. EPIC (largest EHR vendor in the US by market share) just opened an API for some types of medical data. AllScripts and Athena also have open-ish APIs. 5 years ago none, and I mean literally zero, of the EHRs had APIs.
I work at athena and we're dogfooding our API for an increasing number of products/components as it's an easy way to both decouple internal services and improve the API for our partners. From my lowly, uninformed position as a developer, we're growing the number of partners as fast as our team can support at this point.