Stimulus Package IP: Health IT part 1 - the new standard wars?

In the ever debated and updated stimulus plan there is a fair chunk (or equivalent to 27 % of AIG quarterly loss) of 17 billion USD for Health-IT. Read a great summary of the Helth IT implications here and find more info from initiatives here and here. Health IT in a broad sense is using IT to provide better and cheaper healthcare. In this sense it is focused on electronic medical records (EMR), earmarking 17 million in payments for hospitals and practitioners who implement it and also 2 billion for infrastrucure, admin and standardization. Timeframe is also of the essence, standards shall be set by the end of this year and payments will start in 2011.

I intend this to be a series I come back to as I find it interesting for many reasons, here are a few:
1) In my mind it is a great initiative - just imagine having all that data and using algorithms to compare MD's thoughts
2) Interesting to see how governement handles standard setting in just 9 months.
3) There is a provision that an open source initiative must be investigated.
4) Two very interesting and in many ways opposite players, Google and Microsoft, have already started working on this
5) It is a hot topic as it is very much intertwined with ethics, data protection and privacy

Before starting of, I wish to say that I am no expert in EMRs so comments are very welcome and I look forward to learning from them AND updating the series with good thoughts / ideas. I honestly think this is one of the most intertwined tech/legal/business/ethics/IP/standards issues of today.

Part 1 - The new standard wars?
The first thing that brought my attention was the fact that standardization plays such a crucial role in this and also that the government is the one pulling the strings. As this is no new field there is lot of IP already out there and also lot of unconnected systems. This leave to rather large questions regarding standards: "what" and "how". At time of writing I have yet not heard of a czar or some concrete measures being done, but I see endless possibilities for how this can be solved - let me share som toughts on scenarios.

How to set the standard:
* Patent pool with free access
Governmental control of IP through acquisition of key patents related to largest / fastest / best system and then labellig that as the standard and through monetary incentives make it the prevailing one. Could (should) grant free access to the patents and also has funds to do so. Likely subject to heavy lobbying activity prior to choice and thus could suffer critique and in worst case low market penetration.
* Standards Organization
There is nothing ruling out the formation of an "ordinary" standards agency like in many other fields. Relying on market powers, corproate negotiations and wealth redistribution to settle the issues. Risks are of course royalty stacking and an immediate 17 bililion dollar mark-up on total revenues generated until end of stimulus package

What to standardize:
* The whole nine yards
Just choosing one EMR option and then once again using monetary incentives to make in prevail. In theory (as always) this is easy, but in practice some MDs want one kind, some the other, some want voice control, some touch screen interfaces etc. etc. This could be full of criticism as the penalties for not adopting the systems are likely not as high as the pain and frustration for practitioners to us a system they dislike.
*Software
Scalable and quick model, but with less IP possibilities. I would draw the analogy to having all EMR's report in one certain file type so that all data would be imported in one large database (n.b. I'm no computer scientist). I'm also assuming that with software only, there are many privacy issues to consider.
* Interface
Safe but expensive, time consuming and full of interoperability problems. In my mind, given a longer time frame, it could be a safe way to develop a new interface only for EMRs, but in todays wireless world and it's encumberances that could be a monumental task.

Another interesting thought would be if whatever system is chosen then turns into a lawsuit (patent or copyright), which also needs some careful thought. Would the government be ready to tackle trolls or are they more keen on just developing an SOP and suddenly having the EMR market boom only to realize it is totally encumbered.
One final thought, with the blu-ray wars in mind, meaning that blu-ray community was so keen on winning just to make sure. their hardware would be in everyone's home with an ethernet port once we all start downloading movies. One could hope that whoever makes these decisions also thinks one step ahead and try to figure out what long term effects there are of digitising healthcare and having that data, not only focusing on choosing the short term solution best fitting the public opinion.

Marcus Malek
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Biological standardization of functional modules

My exploration into genetic engineering for my M.Sc. thesis has led me to an interesting path of new exciting research in gene synthesis. For those of you that have not been in contact with this topic before, it can simply be described as the synthesis of gene-length DNA from chemically derived oligonucleotides, which in turn are short Feb 23 posting in McKinsey&Company: What matters: ”Over the past few decades, most new jobs, wealth, and growth were created in the knowledge and digital realm. And while venture capital represented only about 0.2 percent of US GDP, the companies it created generated about 17 percent of economic activity. The Internet changed virtually every industry. Yet as far-reaching as the digital revolution was, the ability to code life will likely reach even further.“.

BioBrick Standardization Process
DNA cannot currently be fabricated purely using an in vitro process (it still requires an intermediate step using a host organism, e.g. yeast or E.Coli). Nevertheless, a transition period has certainly begun. An interesting model in regards to this is the BioBrick Foundation that was introduced (according to Wikipedia) by Tom Knight (MIT), Drew Endy (Stanford) and Christopher Voigt (UCSF). The trademarked words BioBrick and BioBricks refer to a specific brand of open source genetic parts, defined via an open technical standards setting process;
1. You develop some scheme for standardizing some aspect of synthetic biology work.
2. You convince at least one other person, at a different location from you, that the scheme would help them with something that they care about.
3. You each demonstrate that the proposed standard works for each of you (i.e., the standard must work and be good for something).
4. You document your scheme in writing.
5. You request a BBF RFC number by asking for one (email the list)
6. The BBF technical standards group (i.e., the folks on this list) comment on the standard, try it out, propose revisions.
7. You revise the standard if necessary.
8. The standard is formally accepted as part of the definition for BioBrick parts. Congratulations, you win (publishers are standing by), the BioBricks technical standards suite is updated.
9. New, possible standards tremble before you! Goto 1.

Productification of Functional Modules
BioBrick parts are DNA sequences held in circular plasmids with precisely defined up- and downstream sequences (both of which are not considered part of the actual BioBrick part). Larger BioBrick parts are simple to create as the up- and downstream sequences contain six restriction sites for specific restriction enzymes allowing for ”chaining together“ of smaller ones. According to the Guardian, there are 3 levels of BioBrick parts;
1) Parts: encode basic biological functions
2) Devices: made from a collection of parts and encode some human-defined functions (such as logic gates in electronic circuits)
3) Systems: perform tasks (such as counting)

Openness
I have not been able to find any IPR policies or ownership governance, but according to an article in Nature Biotech it seems as the objective is to create openness and accessibility: ”Quantitative descriptions of devices in the form of standardized, comprehensive datasheets are widely used in the electrical10, mechanical, structural and other engineering disciplines. [...] We propose to adopt a similar framework for describing engineered biological devices. [...] Finally, because the receiver can be used in many systems and because we hope to promote the collaborative development and unfettered use of open libraries of standard biological parts and devices, all of the information describing the receiver is freely available through the Registry of Standard Biological Parts”

Value Extraction
It will be interesting to see what type of interesting value extraction models that may arise from this open standard. Some early models related to education include;
* The International Genetic Engineered Machine (iGEM) competition
* The Build-A-Genome (BAG) class at John Hopkins University

To paraphrase Barry Schuler in his TED talk Genomics 101, about the fact that it is a fine line between playing god and learning the laws of nature. We are not creating anything artificial we are only changing around the already existing building blocks in nature to understand what the rules of the game are.

Tobias Thornblad

More state-of-the-art gene synthesis:
http://www.cell.com/trends/biotechnology/abstract/S0167-7799(08)00285-0

Patent disclosure and SSO

The court has agreed that failure to disclose essential patents required by the standard setting organization is considered to be a waiver of the patent rights in relation to the standard.

It is interesting to read that the court in Qualcomm Inc. v. Broadcom Corp (Fed. Cir., Dec. 1, 2008) has taken the issue of patent disclosures in standard setting organizations to a new level. There is a separation between organizations where you are required to license your essential patents by default when entering in to the organization and the cases where you explicitly have to disclose the ones you have knowledge about. It sounds reasonable to agree with the court that even if there were no explicit obligaton to disclose, the members of JVT understood it as if they were to disclose. By not disclosing, Qualcomm put the other members in a false understanding of the position when they were deciding upon the new standard.

Since standards are as important as they are, especially in the ICT sector, they also have to be treated as if they are. The economic impact of setting a standard, although a RF one in this case, could be enormous and the investments huge. Therefore we need more understanding of this impact, both in the legal system but more importantly in the SSOs themselves.

I know that there is a rising interest from the actors to look in to the patent policies which I think is good. One could of course ague if it should be constructed to be RF or FRAND, but most importantly is that it is clear to the actors in the organization to have a common understanding. This is where the decision in this Qualcomm case might be a pointer in the direction of more clarity.

Johan Örneblad