Breaking News: Congress Wants to Create National eHealth Network, Legislate Who "Owns" Health Data

Clue - it ain't patients. Google. Microsoft. I hope someone in your healthcare organizations reads this brief. Look especially to the latter 1/3rd.

Browsing Twitter this afternoon, I learned about a House bill draft (HR ____) nicknamed "Health e-Information Technology Act of 2008" from @jesran.

It has not yet been assigned a number, but the draft copy is available here. It looks to be in pre-committee.

Sponsors: Mr. STARK (for himself, Ms. SCHWARTZ, Mr. MCDERMOTT, Mr. MCNULTY, Mr. LEVIN, Mr. EMANUEL, Mr. NEAL of Massachusetts, Mr. PASCRELL, and Mr. LEWIS of Georgia).

IF YOU ARE IN HEALTHCARE, THIS BILL IS THE MOST IMPORTANT THING YOU MAY READ THIS YEAR.

Why is the bill important? Take a look:

• It defines an EHR, and places control of an EHR strictly and SOLELY in the hands of providers and staff (numbers to the left are lines in the bill), p.4:
  

‘‘(1) ELECTRONIC HEALTH RECORD.—The term
18 ‘electronic health record’ means an electronic record
19 of health-related information on an individual that is
20 created, managed, and consulted by authorized
21 health care clinicians and staff of one or more orga
22 nizations, that conforms to standards adopted under
23 section 3003(a), and is made accessible electronically
24 to other health care organizations and other author
25 ized users."

• On p.5, it defines providers as the following, but adds "any other category...determined appropriate by the Secretary":

HEALTH CARE PROVIDER.—The term
2 ‘health care provider’ means a hospital, skilled nurs
3 ing facility, nursing facility, home health entity,
4 health care clinic, Federally qualified health center,
5 group practice (as defined in section 1877(h)(4) of
6 the Social Security Act), a pharmacist, a pharmacy,
7 a laboratory, a physician (as defined in section
8 1861(r)) of the Social Security Act), a practitioner
9 (as described in section 1842(b)(18)(C) of the Social
10 Security Act), a provider operated by, or under con
11 tract with, the Indian Health Service or by an In
12 dian tribe (as defined in the Indian Self-Determina
13 tion and Education Assistance Act), tribal organiza
14 tion, or urban Indian organization (as defined in
15 section 4 of the Indian Health Care Improvement
16 Act), a rural health clinic, and any other category of
17 facility or clinician determined appropriate by the
18 Secretary.

• Pages 5-6 define HIT (line 1 denotes jump to p. 6):

‘‘(4) HEALTH INFORMATION TECHNOLOGY.—
23 The term ‘health information technology’ means
24 hardware, software, integrated technologies and re
25 lated licenses, intellectual property, upgrades, and
1 packaged solutions sold as services that are specifi
2 cally designed for use by health care entities for the
3 electronic creation, maintenance, or exchange of
4 health information. "

WAIT A MINUTE: HIT is "specifically designed for use by health care entities?" Are patients/consumers considered healthcare entities? I'm getting a sick feeling in the pit of my stomach here.

• A new post is born:

"There is established within
8 the Department of Health and Human Services an Office
9 of the National Coordinator for Health Information Tech
10 nology (referred to in this section as the ‘Office’). The Of
11 fice shall be headed by a National Coordinator who shall
12 be appointed by the Secretary and shall report directly to
13 the Secretary."

• Part of his/her job? To pave the way for a "nationwide health information technology infrastructure" that:
  

1. allows for the electronic use and exchange of information
   
2. ensures each patient's health info is secure under 'applicable law' (Hello HIPAA)
3. improves quality
4. reduces medical errors
5. advances delivery of patient-centered medical care
   
6. reduces costs resulting from inefficiency, errors, inappropriate care (say what?) duplicative care and incomplete information
7. ensures appropriate information to help guide decisions is availble at the time and place of care (that one's a doozy - cost? quality data transparency requirements at a national level?)
8. ensures inclusion of meaningful public input (how defined?) in development
9. improves public health reporting
   
10. facilitates research
11. (another doozy) "promotes a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in healthcare services" AKA CONSUMER CENTRIC CARE
12. improves efforts to reduce health disparities (wait, healthCARE delivery disparities or HEALTH disparities?)

• Every 2 years, the National Coordinator and HIT Advisory Commitee must update/make new recommendations. This is a VERY big job. Ted Eytan could take it.
  

• When developing recommendations, the National Coordinator must initially refer to DOD and VA, which are cited as models of interoperability for EHRs (GAO report 08-954 p.6-8 specifically cited in the bill) p. 12.

• The poor National Coordinator must ensure that information is collected and transmitted in "a manner that is reliable, accurate, unambiguous and (wait for it...) based on a uniform provider data set (who defines this Uniform Provider Data Set?)." The coordinator's FIRST TRIP should be to Health 2.0. Next trip to New Zealand. Third trip to Medicine 2.0.

• Sensitive health information may be "segmented" ie broken up into little pieces and scattered into the wind to protect our privacy. Great. Good luck putting that broken picture back together, p. 14.
  

• Shocker: To the "maximum extent appropriate" coordinator must incorporate CCHIT ambulatory and inpatient certification criteria.

• National Coordinator will solicit public input via open public meetings and comment periods, p. 16.

• She will also develop a program "(either directly or by contract)" -ummmm, SOMEONE's getting paid...-for the voluntary certification and periodic recertification of HIT systems and components.

• The National Coordinator needs to be an open-source guru too, using definition of 'open source' as defined by the Open Source Initiative.
  

• She will have to "provide for coordinating the development, routine updating, and provision of an open-source health information technology system that is either new" or based on an existing system. This system must be made "publicly available for use" 9 months after adoption of initial standards by Secretary (laughing, wiping eyes), p.17-18.
  

• National Coordinator shall establish a consortium of tech, legal, clinical geeks familiar with open-source. Hello - patients? I'd give my right arm to be on this consortium. Probably literally.

• OH MY GOODNESS. National Coordinator = Merchant of Venice. She may charge "a nominal fee" for the adoption "by a healthcare provider of the health information technology system" p. 19.
  

Wait a minute.

So not only are we not INCENTIVIZING doctors' use of EHRs, we're going to CHARGE THEM TO USE THE NATIONAL EHR SYSTEM?

But wait. It's all ok. If I'm a smaller provider or in a rural area I may get a price break - there is a "significant hardship exception" available to those working in areas with no Internet access (p.53). Also, hospitals may get paid a million bucks to implement (p.59), PLUS discharge volume incentives. Thanks Uncle Sam.

Also, later (p. 44-45) the bill seems to say (I could be wrong on this quick+dirty read) that IF you successfully implement and become a "meaningful user" by 2014 you get $15k. By 2015, you get 12k, 2016, 8k, 2017, 4k, and by 2018 only 2k to line your pocket.

How do they determine 'meaningful use?' Maybe by looking at drug claims submitted via the system.

Oh, and by the way, the National Coordinator has TWELVE MONTHS to develop a strategic plan detailing how to achieve the above objectives. After which case a straightjacket or lobotomy may be necessary.

The plan must also include timeframes.

The National Coordinator has to publish the strategic plan, and then subsequent implementation reports every 12 months. She can create and use task forces and work groups, in addition to the HIT Advisory Committee, for help here.

Of course, the coordinator also has to do a website, which includes grant information for HIT implementation, and appoint personnel. Staff will be funded by appropriated monies from 2009-2013.

Also, the office gains revenues from an "open source product licensing fee" (p. 26).

So, who are the National Coordinator's Knights of the Round Table? The HIT Advisory Committee. Who's on the Commitee?

1. DHS appointees from AHRQ, CDC, CMS, HRSA, IHS.
2. 1 member pick from Senate majority leader.
3. 1 member pick from Senate minority leader.
4. 1 member pick from Speaker of the House.
5. 1 member pick from House minority leader.
   
6. Presidential appointees from Veterans Affairs, NIST, and DOD. Yep. DOD!

In addition, the HIT Advisory Committee contains a very interesting dozen appointees chosen by the Comptroller General of the US. These '12 disciples' include:

• 1 advocate for healthcare patients and consumers (!)
• 2 healthcare provider reps (1 a doc)
• 1 from labor union (uh oh SEIU, make sure we don't get a doc from BIDMC on here too)
• 1 member with expertise in privacy/security
• 1 w/experience improving health of vulnerable populations
• 1 member from health research
• 1 health plans/3rd party payors
• 1 HIT vendor rep
• 1 shall represent purchasers or employers
  
• 1 w/expertise in healthcare quality measurement and reporting
• 1 w/expertise in open source HIT systems
  

The HIT Advisory Committee will have 1 Chair, 1 Vice Chair, one of whom must be from public sphere, one of whom must be from private sphere. Members are paid a per diem rate and are reimbursed for travel expenses. Members serve 3 yr terms, and 10 constitute a quorum.

STANDARDS SHOULD BE ADOPTED NO LATER THAN SEPTEMBER 30, 2011 (p. 33).

But adoption by "private entities" seems to be voluntary (p.34).

The National Coordinator will develop an HIT Resource Center to develop best practices, provide tech support, and accelerate the aims of the bill.

Now let's move on to carrots and sticks.

CMS and other federal agencies "relating to promoting quality and efficient healthcare in Federal government administered or other sponsored healthcare programs" may require providers to implement the system (play or we don't pay, p.40).


Medicare Advantage plans (MAs) get a variety of special incentives described with a rules schedule that's dizzying - check out pages in the 70s.

Also, there's a $115M pot of grants and loans available from 2009-2013.

Grant and loan programs may also be funded by agencies such as AHRQ available for providers and also for states and Indian tribes. Read pages in the 80s and 90s. Grant and loan recipient must demonstrate sustainability of quality improvements and cost decreases.

Medical Education Evolution folks take note - Special grants and efforts to develop academic curricula that incorporate HIT use and adoption in clinical education are proposed on page 99. Requirements are spelled out on pages 100-103. 10M bucks is available for these initiatives from 2009 -2011.

I can hear the contractors salivating now. In fact, I should start a contracting firm. It'd qualify for minority owned discounts and incentives and I'd be competing in a protected space as a female owner/exec for the duration of these funds (2009-2013). How's that for a Health 2.0 business model?


How will Joe Six Pack and Alaskan Hockey Mom learn about this initiative?

No later than a year after this bill passes (and may God have mercy on our souls), the Office for Civil Rights within DHHS will "develop and maintain a multi-faceted national education initiative" (read - poorly designed website with long, counterintiutive URL where they slap up patronizing information and quizzes) to "enhance public transparency regarding uses of their protected health information, the effects of such uses, and the rights of indivuduals."

This office will spend 10M dollars to implement this campaign. Give me 10k and I'll start a bloggers campaign that would reach more people and generate more buzz.

Big Picture Issue? Great. The government will now have access to my EHR. In fact, the government will OWN my EHR, and pay docs to keep it out of my hands.

Or so it seems at first read. On page 125, however, the bill authors tell me patronizingly that I can "obtain from such covered entity a copy of such information in an electronic format," AND that the provider can't charge me for that copy.

Well, at least they ARE saying the data can't be sold without my permission (page 125).

And on page 128 they say that providers can't use this information for marketing purposes, or to send a communication that "encourages recipients of the communication to purchase or use the product or service." In legal language, they're not considering that a qualified "health care operation."

What Happens if Your Data Gets Out?

Breaches and other privacy and security issues are covered in pages from 103-118; Google, Microsoft, and other PHR vendors will want to read p. 110 closely:

• VENDOR OF PERSONAL HEALTH (p. 110)

2 RECORDS.—The term ‘‘vendor of personal health
3 records’’ means an entity that offers or maintains a
4 personal health record. Such term does not include
5 an entity that is a covered entity for purposes of of
6 fering or maintaining such personal health record.

Big Govt. is also going to take on Google and Microsoft. Read page 131 guys. Read it again. And again.

You heard it here first: 1 year after this Act, the Secretary and the FTC will do a study on privacy+security requirements "to entities that are not considered covered entities" (see page 132, line 7, where the gauntlet is thrown, and your advertisers should you allow any, on line 8, and your partners - perhaps even patients and users, line 15). See also "business associate contracts" page 137.

And little PHR vendors, you're not out of the woods either. The government will investigate clients using your site as a cobranded app or customized PHR portal. See page 132, line 19.

Why you should read this bill draft again, and again, and again:

1. It's a mountain of legislation that makes HIPAA look like a molehill.
2. It also systematically reinforces the position of patient as 'other.'
3. Consumers will not have control over personal health narratives. Our input to PHRs is trivial, 'outside' the system and relevant only for our personal use.
4. This bill would ensure that PHRs and EHRs will forever remain disjointed halves of information necessary to improve care.
5. It does not provide adequate time for the government to develop or acquire such a system.
6. It does not provide adequate incentives or support for docs to implement such a system.
   

But, if you aren't using PHRs by 2018 anyway, I'm betting you're out of business sometime in the next 10 years.

Now, what are you going to do about it?

PS - I nominate Dr. Richard Reece for National Coordinator position. I nominate Dr. Stanley Feld to be the next Secretary of DHHS.

Welkom en Dutch Grand Rounds, Grote Visit - 4th Edition!

Health Management Rx has the unique privilege to host the first US-based Dutch Grand Rounds today!

Due to the language barrier (ours, not theirs!), the format of this Grand Rounds will be text heavy - some posts are in English, some in Dutch.

Our Dutch colleagues have kindly translated many Dutch links to English text for us, so content of those posts is included below en total.

Since we have so much great 'imported' material to cover, I'll keep the intro short and sweet.

It's a privilege to provide inside perspectives from my adopted homeland. This is a rare chance for the American health and medical blogosphere to hear what's really going on over there in the Netherlands, and how Dutch bloggers view international healthcare fumblings.

Or, as e-Patient Dave and Susannah Fox put it recently: "What's with the Dutch?"

What's amazing is we don't often hear about Holland over here in the insular US of A, unless you're a tech and/or design addict (check out Dwell, Wired, Fast Company, etc. to read about the latest, including Dutch design superstars like Tord Boontje). Or a windmill enthusiast.

These are my friends who reclaimed a homeland from the sea, create beautiful art, pottery, food, families and literature, and bought New York before anybody else across the pond could sense future value.

Point: The Dutch are at the forefront of what's new and what's next, in tech, in architecture, in health.

We're building a global network of healthcare firestarters, connecting with new friends in Israel, Canada, Hungary, and of course the USA.

What you need to know about Holland:

1. Yes, we ride bikes. Alot. Ask us about 'oma fiets.'
2. No, we don't wear clogs. Usually.
3. Ignore us at your peril. We are all on Twitter. Are you?

You might say we're a nation where being a maverick is the norm. No wonder I feel so at home...Lekker!

Why pay attention to the Dutch healthcare ecosystem and blogosphere?


1. They are further along in PHR development. And they let people who are patients 'own' medical and health data.

Why does this matter? Because there isn't a snowball's chance in hell we'll reach agreement on who 'owns' data until someone builds a killer app that let both patients and providers have access and sharing/privacy rights.

As John Sharp said on Twitter yesterday:

JohnSharp @jenmccabegorman As Health 2.0 epatients, we can take charge of our health info but the docs still write the scripts 05:05 PM October 06, 2008 from web in reply to jenmccabegorman

I say again, they let PEOPLE WHO ARE PATIENTS OWN MEDICAL AND HEALTH DATA.

From Robert (@hout): PHR-On-A-Stick (Netherlands)

Two doctors at Maastricht University Medical Centre, in cooporation with Cinsol corp., have developed a cardiologic Personal Health Record, on a Flash memory stick, called Cardiostick.

Cardiostick contains personal data, insurance data, and medical info about pacemakers, operations, heart rhythms, x-rays, ECGs and scans.

When plugged into the computer, an emergency page appears with all important medical information in four languages.

The patient owns the Cardiostick and is able to add and edit password protected information. He also can grant access to others (doctors).

Cardiostick is currently being used by apprx. 500 people.

http://www.health20.nl/2008/10/01/epd-on-a-stick/

Good luck ;-)
Robert


2. They are paying attention to genomics. Again, watching where the puck is going, not where it is (thanks @gapingvoid).

From Laika's MedLibLog, an excellent analysis of DTC (direct-to-consumer) genetics firm 23andme's recent price cut in "23andMe: 23andMe, not yet."

Can't believe I missed the "celebrity spit party" - @unitystoakes can you tell us more about it at Stoaked?

And check out the comments in Laika's blog entry, where Dr. Steven Murphy tells us about a new group, HelixGene, dedicated to "better genomic medicine."


3. They've agreed they need a NATIONAL EHR/EMR SYSTEM.

Lodewijk Bos, @icmcc, Founder of the International Council on Medical and Care Compunetics (ICMCC), has an excellent commentary here.

His main point? A tethered EMR will never live happily ever after with an untethered PHR. We need a comprehensive design, or a system to link the two interfaces - and buena suerte with building that one.

Or, as Lodewijk puts it: "The concept of a separate EHR and PHR is fundamentally wrong."

The first article to which Lodewijk refers, by Martijn Hulst, is published in Dutch, but Martijn has been kind enough to translate it for us Dutch n00bs.

From Martijn Hulst comes a translated summary his blog-article about electronic health records (http://www.martijnhulst.nl/weblog/pivot/entry.php?id=472) in Holland.

The post, in Dutch (via the link above) gives an overview of the EHR-debate in the Netherlands.

What you need to know about systemic, national EHR implementation in Holland (per Martijn):

1. The government is trying to get a law through our Parliament.

2. In this law they demand that on September 2009, every caregiver is connected to the main EHR-application, so that the exchange of health data between caregivers is possible.

3. When they made the initial law there were many reactions:

• The Council for Public Health and Health Care said in an article that the whole idea of the EHR and the law isn't looking at what is possible with the web.

• A general practitioner published an article and wrote that the EHR of the government is nothing more than an 'air castle' (castle in the clouds) and that it won't work in such a short period.

• The society of general practicioners aren't willing to help, because they don't believe in the EHR and because there's another discussion between them and the government about payment. (It's always about the incentives eh Martijn?!)
  

• A lawyer, who studied privacy-questions about EHR, said the EHR is not good for the privacy of patients, because caregivers wouldn't have the approval from the patients to look in the health records of their or others patients.

• A consultant about EHR's wrote an opinion-article and said some things about who is owner of the EHR (patient versus physician, another recurring theme).
  

• The insurance companies and the dutch association of patient-consumers (NPCF) said that regardless of the critics we must go on with the law, because patients are waiting on a main EHR-exchange and that it lead to some prevention and less mistakes in healthcare.

4. They believe in consumer-centric, human t0 human care.

From Martijn Hulst:

"In my posting I give another view and write about the world patients live in (the 'health2.0-world'). In this world patients are already exchanging information, meeting each other, monitors online his / her health, and so on. This world is far from the world of the law. And, well, you know already, this is not a technical problem, but an organizational and culture problem. This is also studied in the model of Bettine Pluut (from Zenc). I put a diagram of this model in my posting.

In my conclusion I write that the whole implementation of EHR's must not be a question for IT-companies, but must be a question for organizational-(change)-consultants. You can't force caregivers to work in a short period with a nationwide EHR, you can't force caregivers to exchange their information and you can't force healthconsumers ('im-patients') to choose for an old idea of EHR's, when they already explored online a world of possibilities."

And from Jacqueline, @fackeldeyfinds, a look at putting human-to-human healthcare into practice here.

An Energizer Bunny who outsparks even yours truly, Jacqueline has an overview of the intersection of people and tech (or lack thereof) in healthcare here (in Dutch but check out the images on the slideshow - you'll get the drift).

5. They are connectors extraordinaire who will give anyone a chance. They live well but move around, a lot.

They are statespeople, diplomats and are not shy about taking risks, like including somone blogging about getting rid of a pot belly in Dutch Grand Rounds.

How can you NOT want to make healthier eating choices, in Holland, the US, and abroad, after reading DietBlueBook's description of, ahem, an apple shaped appreciation for good living?

"Hidden under my shirt is a jiggly treasure trove of human belly fat - perfect for some fun loving squeezing and a show of wealth perhaps in some poorer countries, but to me, it’s a sad reminder that I’m out of shape and have been hitting the ice cream cartons and Asian carryout meals a bit too hard."

Yeah, really I just couldn't figure out how to fit this one in there (no pun intended).

But eat too much pie in Holland and you too will be dealing with Dutch double belly.

AdmirableIndia's post, has, on the other hand, nothing specifically to do with healthcare, or Holland, but DOES have some very nice therapeautic photos of sunflowers.

AND since Van Gough was particularly fond of this flora, you made it in by a hair AI.

Thanks for brightening our day.

Tomorrow a quick followup and announcement of the next gathering place for Dutch Grand Rounds.


Until then, be well, do good work, and think seriously about booking a trip to Holland.

Tulip fields are lovely in the spring, and I know a little place we can brainstorm.

Tot ziens all!

Part III: Go Edupunk - Healthcare Incubators: Time to Burn or Become Steel

Blogger's Note: Today I'm skipping around a bit during our week-long look at healthcare incubators.

Before we look at when incubators in healthcare/startup health WON'T work, let's take a look at what's working from the business end of startup tech incubation.

Part of the problem with incubation in startup health is that startup tech has been playing this game for at least 2 decades.

As a result, they've got a cast of characters - expected players who will scoop in and pick off any smaller firms whose products and services they want to integrate.

Want the ultimate exit? Look for acquisition by Google, Microsoft, Yahoo, etc.

But it wasn't until earlier this year that Microsoft and Google's health interests pushed them into releasing PHRs. In health, we couldn't look to the big boys for adoption. But that's changing as we move towards consumer-centric care.

So who might we expect to see adopting healthtech incubators' grads? Of course the same cast of characters is now attending to our space, so you might go after Google, MS, Yahoo.

But what about other firms?

Of course you could look to big pharma if you've got biotech grit, or one of the DTC genomics firms like 23andme if you're working in genetics/medtech equipment or processing.

But what about hospitals? Are big brick and mortar healthcare factories looking at investment in startup health?

Sure, but probably not at the level of a total acquisition - they're much more likely to cough up cash for partnerships or to pay for leasing/subscription/installation/service/support fees.

Wait a hot second...That's AT LEAST 4 big potential markets for health startups (big tech, pharma, biotech/genomics, hospitals).

So why aren't we seeing more incubators birthed to take advantage of a group of buyers with big wallets in a space that's, as Unity Stoakes puts it in this Organized Wisdom interview with Esther Dyson, "under-focused on and under-funded?"

It's crucible time for consumer-centric healthcare tech; as a recent issue of SmartBrief Leadership e-newsletter put it, time to "burn or become steel."

The Health 2.0 movement is at a precarious turning point ("the terrible 2s") - we've got companies with some very interesting traction, large community strength numbers, and even a few with some revenues in the black (a very few).

But the cyclical boom/bust nature of tech movements, including startup tech in health, opens wide the doors of opportunity for investors and larger big money sector leaders to fund incubation.

For goodness sake - we're dealing with people's most precious asset (even above financial security) - if you don't have life and limb intact it'll be hard to enjoy the fruits of the post-bailout economy.

You'd think more companies and individuals would be flocking to the space to look at incubation and VC/mentoring networks. But it's still a pretty insular world.

If startup tech can be THIS creative - with an online artisan food marketplace I love, Foodzie, birthed in the 2008 TechStars incubator, blogging about a "Magic of Mole" cooking class (warning: 'gastroporn' alert - do not look at the Foodzie page while hungry!) at La Cocina, an incubator for food entrepreneurs - SO CAN STARTUP HEALTH.

Want to see more examples of startup tech incubatees? Here's a look at some of the firms in the Y Combinator stable.

If you want more startup tech ed, check out this short video interview with VC investor Brad Feld, who reminds us that incubators are NOT the same as angel investing. But angels are a series for another time...

ADDITION: Just to really get your bloomers in a bunch, here's an irreverent panel at CommunityNext moderated by Guy Kawasaki that blows business model and 'standard' VC value benchmarks right out of the water.

The point? We need more innovation in HIT, eHealth and mHealth, not less.

I'd like to see increasing design-consciousness among medical equipment manufacturers in particular - haven't they learned anything from Amy Tenderich's open letter to Steve Jobs and the Diabetes Mine Design Challenge?

Need examples of the kind of innovation I'm talking about, and how it might be specifically translated to healthcare incubator selection?

• Reserve a spot in an incubator for a medical equipment maker looking to integrate biomimicry.

• Recruit a company, or university team, looking at bringing a product to market related to accessibility and gaming.
  

• A no brainer? A startup team designing a fitness game for the Nintendo Wii or for wiihabilitation.

Startup health incubator. Steel health. Steal Health? Crucible? Hmmm. I like it.

I like it alot.

Any investors want to do a startup health incubator?

Tune in tomorrow for when incubators in health WON'T work, and a discussion of the elephants in the room, including IP.